Propofol Group Research Articles

Impact of Propofol Administered before Extubation on Respiratory Adverse Events in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Randomized Controlled Trial

Aims/Background Perioperative respiratory adverse events (PRAEs) are common in pediatric anesthesia, especially in otolaryngology procedures. In this randomized controlled trial, we investigated the impact of administering propofol before extubation on PRAEs in pediatric patients undergoing tonsillectomy and adenoidectomy. Methods We enrolled children aged 3 to 8 years old, of American Society of Anesthesiologists (ASA) classes I to III, scheduled for tonsillectomy, and randomly divided them into propofol and control groups. The subjects in the propofol group received multiple small doses of propofol (0.5 mg/kg per dose, total 1–2 mg/kg) until the patient resumed regular spontaneous breathing and exhibited no bodily movements. The subjects in the control group received 0.15 mL/kg of saline. The primary outcome was the rate of PRAEs, such as laryngospasm, bronchospasm, breath-holding spell, severe coughing, desaturation, and airway obstruction, post-extubation. The secondary outcomes were the extubation time, pre-extubation Richmond Agitation-Sedation Scale (RASS) score, end-tidal sevoflurane concentration at extubation, incidence of postoperative agitation, time to consciousness, and Face, Legs, Activity, Cry, and Consolability (FLACC) pain score in the recovery room. Results were reported with risk ratios (RR) and their 95% confidence intervals (CI), as well as the p-values indicating statistical significance. Results A total of 239 patients were included, including 119 in the propofol group and 120 in the control group. Our findings indicated no significant difference in the rate of PRAEs between the two groups (5.9% vs 10.8%, RR: 0.54, 95% CI: 0.23 to 1.31, p = 0.17). However, the propofol group showed a notable decrease in moderate to severe coughs (13.4% vs 60.0%, RR: 0.22, 95% CI: 0.14 to 0.36, p < 0.001) and postoperative agitation (4.2% vs 60.8%, RR: 0.07, 95% CI: 0.03 to 0.17, p < 0.001). Conclusion This trial demonstrated that while administering repeated small doses of propofol before extubation does not significantly reduce respiratory adverse events in children undergoing tonsillectomy and adenoidectomy, it does significantly reduce the incidence of severe coughing, improving postoperative recovery and clinical outcomes. Moreover, propofol helps reduce postoperative agitation, enhancing the safety and effectiveness of postoperative care, and maintaining its valuable clinical role in postoperative management. Clinical Trial Registration ClinicalTrials.gov ( NCT05769842 ).

The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy: a randomized, double-blind, controlled trial.

Studies have reported that ciprofol has the advantage of reducing injection pain compared to propofol during gastroscopy, colonoscopy, and fiberoptic bronchoscopy. The effect of ciprofol on the injection pain in painless hysteroscopy needs to further explore. A double-blind randomized controlled trial (RCT) was designed, and patients were recruited from the First Central Hospital of Baoding from March 2024 to June 2024. The eligible participants were allocated into ciprofol group (ciprofol combined with alfentanil) and propofol group (propofol combined with alfentanil) at 1:1 ratio. The primary outcome was injection pain. The secondary outcomes included sedation success rate, anesthesia success rate, adverse events, patient satisfaction, and comparison of vital signs before and after administration. A total of 217 participants were included for analysis, with 109 participants in the ciprofol group and 108 participants in the propofol group. The injection pain rate of ciprofol group (18.35%) was significantly lower than the propofol group (40.74%). Both the ciprofol group and propofol group had 100% of the sedation success rate. The anesthesia success rate between the two groups was comparable (P > 0.05). The rate of adverse events was lower (27.52% vs. 45.37%) and patient satisfaction was higher (9.84 ± 0.45 vs. 9.65 ± 0.85) in the ciprofol group than the propofol group. In addition, values of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in propofol group were significantly lower than those in ciprofol group at the time of cervical dilation and consciousness recovery. Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy. NCT06413862.

Ciprofol versus propofol for anesthesia induction in cardiac surgery: a randomized double-blind controlled clinical trial.

Ciprofol, a novel intravenous general anesthetic with a chemical structure similar to propofol, exhibits significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and has comparable effects on heart rate and blood pressure to propofol. However, clinical data on its use for anesthesia induction in cardiac surgery remain limited. Seventy-eight patients undergoing coronary artery bypass grafting or valve replacement surgery were randomly assigned to receive either ciprofol (N = 40) or propofol (N = 38) for anesthesia induction. Variables recorded included changes in mean arterial pressure and heart rate during anesthesia, alterations in the oxygenation index and lactic acid concentration before and 10min after anesthesia induction, and the incidence of adverse events such as bradycardia, hypotension, and injection pain. The incidence of anesthesia-induced injection pain was significantly lower in the ciprofol group compared to the propofol group (3% vs. 18%, P < 0.05). The incidence of other adverse events was similar between the groups. No significant differences in hemodynamics or oxygenation index were observed during anesthesia induction between ciprofol and propofol. Ciprofol demonstrated a significantly lower incidence of injection pain compared to propofol, potentially improving patient comfort during anesthesia induction. Additionally, ciprofol showed comparable circulatory stability to propofol during anesthesia induction in cardiac surgery, suggesting it may be a suitable alternative to propofol for this application. The trial was registered at the ClinicalTrials.gov on 03/10/2024 (NCT06312345).

Effect of remimazolam on oxygen reserve compared with propofol during upper gastrointestinal endoscopy: Randomized controlled study.

Propofol is commonly used for endoscopic sedation. However, it can induce adverse hemodynamic effects. Remimazolam is known to have a fast onset and short duration comparable to that of propofol, but with fewer effects on hemodynamics. We assessed the Oxygen Reserve Index to verify whether a sedative dose of remimazolam would better preserve oxygenation in the mild hyperoxic range than propofol in sedated patients undergoing diagnostic upper gastrointestinal endoscopy. Patients scheduled for diagnostic upper gastrointestinal endoscopy were enrolled. Patients were randomly assigned to either the remimazolam or propofol groups and received 0.1 mg/kg remimazolam or 0.5 mg/kg propofol, respectively. Bolus injections of either 0.05 mg/kg remimazolam or 0.25 mg/kg propofol were added if required. The primary outcome was the prevalence of oxygen reserve depletion, defined as the Oxygen Reserve Index decreasing to 0.00, and hypoxia defined as peripheral oxygen saturation falling to <94%. Among 69 patients, the incidence of oxygen reserve depletion was significantly higher in the propofol group (65.7% vs. 38.2%, P = 0.022). Hypoxia was frequently observed in the propofol group, whereas none was observed in the remimazolam group (11.4% vs. 0%, P = 0.042). Additional sedative injections were frequently required to complete endoscopy in the propofol group. None of the patients in the remimazolam group required airway interventions. Nausea was frequent in the propofol group in the recovery room. Our results indicate that remimazolam is a safe and useful sedative for upper gastrointestinal endoscopy.

Pulmonary Atelectasis After Sedation With Propofol vs Propofol-Ketamine for Magnetic Resonance Imaging in Children

Little is known about the impact of different anesthetic agents used for routine magnetic resonance imaging (MRI) sedation on pulmonary function in children. To compare the incidence of pulmonary atelectasis after MRI sedation with propofol vs propofol-ketamine. This double-masked randomized clinical trial screened 117 consecutive pediatric patients aged 3 to 12 years with American Society of Anesthesiologists physical status I to II undergoing elective MRI under deep sedation from November 2, 2022, to April 28, 2023, at a tertiary referral center. Four patients met the exclusion criteria, and 5 patients refused to participate. The participants and outcome assessors were masked to the group allocation. During the MRI, the propofol group received 0.2 mL/kg of 1% propofol and 2 mL of 0.9% saline followed by a continuous infusion of propofol (200 μg/kg/min) and 0.9% saline (0.04 mL/kg/min). The propofol-ketamine group received 0.2 mL/kg of 0.5% propofol and 1 mg/kg of ketamine followed by a continuous infusion of propofol (100 μg/kg/min) and ketamine (20 μg/kg/min). The incidence of atelectasis assessed by lung ultrasonography examination. A total of 107 children (median [IQR] age, 5 [4-6] years; 62 male [57.9%]), with 54 in the propofol group and 53 in the propofol-ketamine group, were analyzed in this study. Notably, 48 (88.9%) and 31 (58.5%) patients had atelectasis in the propofol and propofol-ketamine groups, respectively (relative risk, 0.7; 95% CI, 0.5-0.8; P < .001). The incidence of desaturation and interruption of the MRI due to airway intervention or spontaneous movement did not significantly differ between the groups. The propofol-ketamine group showed a faster emergence time than the propofol group (15 [9-23] vs 25 [22-27] minutes in the propofol-ketamine vs propofol group; median difference in time, 9.0 minutes; 95% CI, 6.0-12.0 minutes; P < .001). No patient was withdrawn from the trial due to adverse effects. In this randomized clinical trial, the propofol-ketamine combination reduced sedation-induced atelectasis while allowing for faster emergence compared with propofol alone. cris.nih.go.kr Identifier: KCT0007699.

Bispectral Index-Monitored Anesthesia Induction in Older Adults Undergoing Elective Surgery: Comparing Ciprofol and Propofol in a Prospective, Single-Center, Double-Blind, Randomized Controlled Study.

Ciprofol, a new sedative anesthetic developed in China, offers rapid onset and recovery, reduced injection pain, and stable circulation. However, its effect on blood pressure during anesthesia induction in older adults remains unclear. To compare the effects of propofol and ciprofol on hypotension induced by general anesthesia in older adults. This prospective, single-center, double-blind, randomized, controlled clinical study enrolled 117 older adults undergoing surgery. Patients in the ciprofol group (group C) received an intravenous injection of ciprofol (0.3 mg/kg, n=57), while the propofol group (group P) received an intravenous injection of propofol (1.5 mg/kg, n=58). The primary outcome was the incidence of hypotension (mean arterial pressure (MAP) decreased by > 30% from baseline or MAP< 65mmHg). Secondary outcomes included induction success rate (bispectral index (BIS) value ≤60 and Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) score ≤1), injection pain, number of drug additions, time to BIS 60, time to eyelash reflex disappearance, blood pressure changes, incidence of hypertension, tachycardia and BIS values before and after administration. The incidence of induced hypotension was 26.3% (15/57) in group C and 48.3% (28/58) in group P (OR=0.383, 95% CI:175-0.837, P =0.015). Group C had significantly lower injection pain incidence (5.3% vs 20.7%, OR=0.213, 95% CI: 0.057-0.801, p=0.014). Both groups had a 100% induction success rate, with no significant difference in the number of additional doses. Post-intubation hypertension and tachycardia incidence were not significantly different. Group C showed less blood pressure decrease during induction and a deeper anesthesia level. Compared to propofol, ciprofol reduces the incidence of induced hypotension in older adults and maintains more stable blood pressure during induction. Additionally, ciprofol reduces injection pain and provides a good depth of anesthesia, making it a safe and effective option for anesthesia induction in older adults. ChiCTR2200066053.

Efficacy and safety of ciprofol for general anesthesia induction in female patients with frailty: a prospective randomized controlled trial

BackgroundCiprofol, a recently developed anesthetic agent, is not inferior to propofol in terms of efficacy and safety. However, most previous clinical experience with ciprofol was based on a robust population. This study aimed to investigate the efficacy and safety of ciprofol for anesthesia induction in female patients with frailty.MethodsThis prospective randomized controlled trial included patients with frailty undergoing elective general anesthesia for gynecological surgery. Frailty was assessed using the modified frailty index. The patients were randomly administered propofol (2 mg/kg) or ciprofol (0.5 mg/kg) during anesthesia induction. The depth of anaesthesia was continually monitored by the bispectral index. The primary outcome was the lowest systolic blood pressure (SBP) during anesthesia induction. Secondary outcomes included the incidence of general anesthesia induction failure and adverse events.ResultsAmong the 69 enrolled patients with frailty, 67 were included in the final analysis. The success rate of anesthesia induction was 100% in both groups. The lowest SBP was significantly higher in the ciprofol group than in the propofol group (103 [96–110] vs. 90 [85–98] mmHg, respectively; P < 0.001), suggesting that the former caused less inhibition of hemodynamics during anesthesia induction in patients with frailty. The incidence of injection pain was lower in the ciprofol group than in the propofol group (3 [8.8%] vs. 11 patients [33.3%], respectively; P = 0.014).ConclusionsThe results of this study suggest that the efficacy of ciprofol for inducing general anesthesia in patients with frailty is comparable to that of propofol, with more stable hemodynamics.Trial registrationThe trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry (www.chictr.org.cn) (Clinical trial number: ChiCTR2300075271; https://www.chictr.org.cn/showproj.html?proj=205160, principal investigator’s name: Zifeng Xu, date of registration: 31/08/2023).

A Comparative Study of Magnesium Sulfate, Lignocaine, and Propofol for Attenuating Hemodynamic Response During Functional Endoscopic Sinus Surgery Under General Anaesthesia: A Prospective Randomized Trial.

This study functional endoscopic sinus surgery (FESS) is a surgical procedure requiring minimal bleeding to optimize the surgical field. This study aimed to evaluate the effectiveness of magnesium sulfate, lignocaine, and propofol in attenuating hemodynamic response. The primary objective of this study was to compare the efficacy of these agents in reducing hemodynamic response. The secondary objectives included assessing the quality of the surgical field, recovery time, and total neuromuscular dose. We randomly allocated 105 patients scheduled for FESS into three groups: lignocaine, propofol, and magnesium sulfate. Heart rate and mean arterial pressure were recorded every 5 min for the first 30 min, followed by measurements every 10 min at the end of the procedure. Moreover, recovery time, total neuromuscular blocking dose, and surgical field score were noted upon completion of the procedure. Statistical analysis was conducted using the number cruncher statistical systems version 9.0.8 software. All three groups showed comparable hemodynamic response and surgical field scores. The recovery time was notably longer in the magnesium sulfate group [10.94 min (2.45)] than in the lignocaine [4.37 min (1.03)] [95% confidence interval (CI) -7.32, -5.83; P=0.000] and propofol groups [4.60 min (0.60)] (95% CI 5.60, 7.095; P=0.000). Moreover, the total neuromuscular blocking agent used was significantly lower in the magnesium sulfate group [5.89 mg (0.47)] than in the lignocaine [6.26 mg (0.56)] (95% CI 0.66, 0.03; P=0.035). Propofol, magnesium sulfate, and lignocaine exerted equal efficacy in attenuating hemodynamic responses during surgery and ensuring a satisfactory surgical field. However, magnesium sulfate led to significantly longer recovery times compared with propofol and lignocaine. In addition, magnesium sulfate required a significantly lower total dose of neuromuscular blocking agents than lignocaine.

Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials

BackgroundCiprofol was approved for use in intensive care unit (ICU) patients requiring sedation during mechanical ventilation in July 2022. A pooled post-hoc analysis of phase 2 and phase 3 trials was conducted primarily to explore hypotension-free outcome in ICU patients who required mechanical ventilation and achieved the target light sedation goal at an early stage after being sedated with ciprofol or propofol.MethodsAll eligible ICU patients who were expected to require sedation for 6–24 h were randomly assigned in a 2:1 ratio to either a ciprofol or propofol group. Ciprofol or propofol was initially infused at loading doses of 0.5 or 1.0 mg/kg followed by maintenance doses of 0.3 or 1.5 mg/kg/h. Ciprofol or propofol dosages were adjusted up or down at rates of 0.05–0.10 mg/kg/h or 0.25–0.50 mg/kg/h, respectively, to achieve the target light sedation (a Richmond Agitation-Sedation Scale of -2 to + 1). The primary post-hoc outcome was the hypotension-free rate in patients who had achieved the target sedation goal after 30-min administration of ciprofol or propofol.ResultsIn total, 174 patients were enrolled for pooled post-hoc analysis, of whom 116 and 58 were assigned to the ciprofol and propofol groups, respectively. The hypotension-free rate was significantly higher in patients who achieved the target sedation goal after 30-min administration of ciprofol (93.0% vs. 81.0%, P = 0.018), and especially in the subgroups of males and patients aged < 65 years. Multivariable analysis revealed that ciprofol treatment, a younger age and lower baseline body mass index were independent favorable predictors for a higher hypotension-free rate in patients who achieved the target sedation goal after 30-min of drug administration. Moreover, hypotension-free patients who reached the target sedation level after 30 min had a more favorable short-term prognosis including a lower incidence of drug-related treatment-emergent adverse events, shorter time to extubation and fewer dose adjustments of ciprofol or propofol (all P < 0.05).ConclusionICU patients undergoing mechanical ventilation and sedated with ciprofol had significantly lower rate of hypotension during the early phase of achieving light sedation during a 6–24 h period, leading to a more favorable short-term prognosis (within 24 h).Trial registrationPhase 2 trial (clinicaltrials.gov, NCT04147416. Registered November 1, 2019, https://classic.clinicaltrials.gov/ct2/show/NCT04147416) and phase 3 trial (clinicaltrials.gov, NCT04620031. Registered November 6, 2020, https://classic.clinicaltrials.gov/ct2/show/NCT04620031).

A Comparison of Remimazolam versus Propofol on Blood Pressure Changes During Therapeutic Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial.

Intraoperative hypotension is the most common adverse event in endoscopic retrograde cholangiopancreatography (ERCP) and is usually attributed to the vasodilatory effect of the anesthetic. The aim of this randomized controlled trial was to evaluate the impact of remimazolam versus propofol on blood pressure changes during the therapeutic ERCP procedure. Adult patients scheduled for elective therapeutic ERCP were randomized to receive either remimazolam or propofol anesthesia (40 patients in each group). The primary outcomes included the change in mean arterial pressure (MAP) during induction and the area under the baseline (AUB), calculated as the blood pressure below baseline multiplied by the duration, throughout the procedure. These measures, respectively, indicated the severity of blood pressure decrease during anesthesia induction and the overall impact of blood pressure changes throughout the procedure. Any incidences of hypotension, defined as MAP <65 mm Hg for at least 1 minute, were recorded. The recovery time and any adverse events were also reported. The change in MAP after induction was smaller in the remimazolam group compared to the propofol group (-7.5 [-14.0 to 0] mm Hg vs -25.0 [-33.8 to -14.3] mm Hg), with a median difference of 17.0 mm Hg (95% confidence interval [CI], 12.0-22.0; P <.001). The AUB in the remimazolam group was less than in the propofol group (-373 [-82 to -854] mm Hg·min vs -705 [-272 to -1100] mm Hg·min), with a median difference of 255 mm Hg·min (95% CI, 29-477; P =.021). The incidence of hypotension was significantly lower for remimazolam than propofol (5% vs 30%; P =.006). There were no serious adverse events in either group. Remimazolam may be considered as an alternative to propofol for general anesthesia during therapeutic ERCP procedures, with the potential advantage of stable hemodynamics.

Postoperative quality of recovery comparison between ciprofol and propofol in total intravenous anesthesia for elderly patients undergoing laparoscopic major abdominal surgery: A randomized, controlled, double-blind, non-inferiority trial

Study objectivesWe conducted a non-inferiority study to assess the postoperative quality of recovery (QoR) in elderly patients receiving ciprofol or propofol total intravenous anesthersia(TIVA)after elective laparoscopic major abdominal surgery, with QoR-15 scores as the main measure. DesignA prospective, double-blind, randomized non-inferiority trial was conducted in the theater, post-anesthesia care unit (PACU), and the ward. Participants144 elderly patients (age ≥ 65 years) were randomly assigned to either the ciprofol group or the propofol group. InterventionsThe ciprofol group received continuous infusion of ciprofol with remifentanil, and the propofol group received infusion of propofol with remifentanil. Outcome measuresThe primary outcome was the QoR-15 on the first postoperative day (POD1), assessed in both intention-to-treat and per-protocol populations, with the mean difference between groups compared to a non-inferiority threshold of −8. Additional assessments included QoR-15 scores on POD2, 3, and 5 for both analysis sets. Other evaluated perioperative value factors included hemodynamic parameters and injection discomfort in the intention-to-treat analysis. A linear mixed model was utilized to examine the impact of group-time interactions on hemodynamic data and QoR-15. Main resultsThe QoR-15 scores on POD1 in the ciprofol group were non-inferior to those in the propofol group both in intention-to-treat set (mean [95 %CI], 95.9[93.7–98.2] vs. 95.6 [93.3–97.8]; mean difference [95 % CI], 0.4 [−2.8–3.5]; P<0.001 for noninferiority) and per-protocol set (mean [95 %CI], 96.7 [94.4–99.0] vs. 95.7 [93.4–98.0]; mean difference [95 % CI], 1.0 [−2.2–4.3]; P<0.001 for noninferiority). Comparable outcomes were noted on postoperative days 2, 3, and 5 following the procedure in both analysis sets. Additionally: compared with propofol group, the occurrence of injection pain was lower (2.8 % vs. 27.8 %, P < 0.001); the hypotension was less frequent (33.3 % vs. 54.2 %, P = 0.012); the bradycardia was more common (38.9 % vs. 23.6 %, P = 0.048). ConclusionsCiprofol is not inferior to propofol in QoR. Ciprofol can be suitably administered to elderly patients undergoing elective laparoscopic major abdominal surgery.

Comparative analysis of the therapeutic efficacy of remimazolam tosylate and propofol in older adults undergoing painless endoscopic retrograde cholangiopancreatography.

The aim of this study is to conduct a comparative analysis of the therapeutic outcomes associated with the administration of remimazolam and propofol during painless endoscopic retrograde cholangiopancreatography (ERCP) procedures in older adults. A total of 140 older adults who underwent elective painless ERCP were randomly assigned to two groups using the random number table method: the remimazolam group and the propofol group, each consisting of 70 patients. In the remimazolam group, anesthesia was administered using a combination of remimazolam and opioids, while in the propofol group, a combination of propofol and opioids was used. Comparative assessments between the two groups included anesthesia induction time, first induction success rate, intraoperative hemodynamics, awakening duration, stress response index, and the incidence of adverse reactions. The remimazolam group exhibited a prolonged anesthesia induction time compared to the propofol group and a lower success rate of first induction (P < 0.05). At the point of endoscope entry (T2) and 10min post-operation (T3), patients in the remimazolam group demonstrated higher mean arterial pressure (MAP), heart rate (HR), and bispectral index (BIS) values compared to those in the propofol group (P < 0.05). Furthermore, the remimazolam group had shorter durations for eye-opening, consciousness recovery, and residence in the recovery room compared to the propofol group (P < 0.05). Post-surgery levels of epinephrine (E), norepinephrine (NE), and cortisol (Cor) at 24h were lower in the remimazolam group than in the propofol group (P < 0.05). The incidence of adverse reactions was significantly lower in the remimazolam group (18.57%) compared to the propofol group (31.43%) (P < 0.05). Remimazolam exhibits a longer induction time compared to propofol in the painless diagnosis and treatment of ERCP in older adults. However, it provides a more stable circulatory state post-induction and throughout the operation, reduces stress response, enables rapid recovery, and has a lower incidence of serious adverse reactions. These attributes suggest that remimazolam has potential for widespread clinical application and adoption. clinicaltrials.gov, identifier ChiCTR2400080926.

Comparison of hypotension between propofol and remimazolam-propofol combinations sedation for day-surgery hysteroscopy: a prospective, randomized, controlled trial

BackgroundA combination of remimazolam and propofol could produce more stable sedation. A good medication regimen should consider not only efficacy but also safety, especially hypotension. The aim of the current study was to compare the incidence and amount of hypotension by propofol versus remimazolam-propofol combinations in day-surgery hysteroscopy.MethodsPatients were randomly assigned to receive either propofol (Group P, n = 125) or remimazolam-propofol combinations (Group RP, n = 125) at a 1:1 ratio. Intravenous injection of sufentanil 0.1ug/kg were administered before sedative medication. In group P, a bolus of 2.5 mg/kg propofol was administered. In group RP, intravenous anesthesia was commenced with 0.125 mg/kg remimazolam and 1 mg/kg propofol. After loss of consciousness, propofol was maintained at 6 mg/kg/h. The primary outcomes were the incidence and amount of hypotension during surgery. Hypotension was defined as a MAP less than 65mmHg for at least 1 min. The amount of hypotension was assessed by time-weighted average intraoperative MAP under a threshold of 65 mmHg. The secondary outcomes were various anesthesia related parameters and some adverse events.ResultsIn group P, 25 patients (20.0%) experienced hypotension during hysteroscopy compared with 9 patients (7.2%) in group RP, for a difference of 12.8% (RR 2.778, 95%CI [1.352–5.709]). The combination of remimazolam and propofol resulted in significantly lower TWA (Time Weighted Average) threshold 0.14 (0.10–0.56) mmHg in group RP compared to 0.31 (0.15–0.67) mmHg in group P. The total dose of propofol was nearly double in group P compared to group RP. A significantly higher frequency of injection pain and low oxygen saturation was observed in the group P than that of the group RP. Hiccup was observed only in group RP. The incidences of body movement, bradycardia and vomiting were no significant difference between groups.ConclusionThe incidence and amount of hypotension by remimazolam-propofol combinations was significantly less than that by propofol sedation in day-surgery hysteroscopy. The optimization of medication regimen would attenuate the harm of hypotension and contribute to patients’ rapid recovery in day surgery.Trial registration Chinese Clinical Trial Registry, ChiCTR2400079888 (date: 15/01/2024),

Utilization of NIRS Monitor to Compare the Regional Cerebral Oxygen Saturation Between Dexmedetomidine and Propofol Sedation in Mechanically Ventilated Critically ill Patients with Sepsis- A Prospective Randomized Control Trial.

Delirium frequently occurs in the acute phase of sepsis and is associated with increased ICU and hospital length of stay, duration of mechanical ventilation, and higher mortality rates. We utilized the Near-Infrared Spectroscopy monitor to measure and compare the regional cerebral oxygen saturation in mechanically ventilated patients of sepsis receiving either dexmedetomidine or propofol sedation and assessed the association between delirium and regional cerebral oxygen saturation. A single center prospective randomized control trial conducted over a period of two years, 54 patients were included, equally divided between propofol and dexmedetomidine groups. Patients received a blinded study drug, propofol (10 mg/mL) or dexmedetomidine (5 mcg/mL) via infusion pump according to randomization. Infusion rates were adjusted every 10 min based on weight-based titration tables, aiming for target sedation (RASS -2 to 0). Management components included pain monitoring using the CPOT score and delirium assessment using CAM-ICU score. Dexmedetomidine group showed higher mean regional cerebral oxygen saturation as compared to propofol group (P = .036). No significant differences were found in mechanical ventilation or ICU stay durations, delirium-free days, or sedation cessation reasons. Delirium occurred in 36 patients, with lower mean regional cerebral oxygen saturation as compared to non-delirious patients. The dexmedetomidine group had higher regional cerebral oxygen saturation compared to the propofol group. Delirious patients showed lower cerebral oxygen saturation than non-delirious patients, suggesting a link between sedation type, cerebral oxygenation, and delirium.CTRI registration: REF/2021/11/048655 N.

Effect of remimazolam for general anesthesia on postoperative nausea and vomiting : Asystematic review and meta-analysis.

Benzodiazepines reduce postoperative nausea and vomiting (PONV); however, conflicting results have been reported regarding the use of remimazolam, anovel benzodiazepine. This meta-analysis examines whether remimazolam reduces PONV incidence compared with propofol or volatile agents used in general anesthesia. Electronic databases, including PubMed, EMBASE, CENTRAL, and Web of Science, were searched on 31 July 2023. The primary outcome was the incidence of PONV. Secondary outcomes included PONV severity, rescue antiemetic use, amounts of remifentanil used, and participant satisfaction scores. Odds ratios (OR) and mean differences (MD) with 95% confidence intervals (CI) were calculated using arandom-effects model. The risk of bias (RoB) was assessed using the Cochrane RoB2 tool. Atotal of 1514 adult patients from11 randomized controlled trials were included. The incidences of PONV in the remimazolam and control groups were 16.1% and 16.5%, respectively. Remimazolam did not increase the incidence of PONV (OR 0.62; 95% CI, 0.37-1.04; p = 0.0676; I2 = 48%). Subgroup analysis showed asignificant reduction in PONV with remimazolam vs. volatile agents (OR 0.25; 95% CI, 0.13-0.47; P = 0.0000; I2 = 0%) but not vs. propofol (OR 1.04; 95% CI, 0.70-1.56; p = 0.8332; I2 = 0%). More remifentanil was used in the remimazolam group vs. the volatile group, with no significant difference between remimazolam and propofol groups. Participant satisfaction scores were higher with remimazolam. Remimazolam did not increase PONV risk compared to propofol and reduced PONV incidence compared to volatile agents, with higher participant satisfaction. To validate the present findings, further well-planned large clinical trials are required.

The efficacy and safety of remimazolam tosilate compared with propofol for endoscopic retrograde cholangiopancreatography under monitored anesthesia care: A single-center randomized controlled clinical trial

BackgroundAlthough remimazolam tosilate is an ultra-short-acting benzodiazepine that causes less respiratory and circulatory depression than propofol, studies evaluating its efficacy and safety during endoscopic retrograde cholangiopancreatography (ERCP) are limited. This study aimed to compare the efficacy and safety of remimazolam and propofol for ERCP performed under monitored anesthesia care (MAC). MethodsThis study is a randomized controlled clinical trial featuring a noninferiority design. A total of 102 eligible patients undergoing ERCP under MAC were randomly assigned to either the remimazolam tosilate group (R group) or the propofol group (P group) in a 1:1 ratio. Patients in the R group were sedated with remimazolam tosilate, while those in the P group received propofol, both under MAC. The primary efficacy endpoint was the success rate of ERCP completion under MAC. Secondary outcomes included the time to loss of consciousness, sedative effects, and perioperative adverse events at various time points for patients in both groups. ResultsBaseline characteristics of both groups were similar. The successful completion rate for ERCP under MAC was 100 % in the R group and 96.1 % in the P group, resulting in a difference of 3.92 % (95 % CI: −2%, 10 %). This difference met the pre-established criterion of being greater than −8%. The total number of norepinephrine infusions, as well as the incidence of intravenous injection pain, post-induction hypotension, post-induction bradycardia, intraoperative hypotension, respiratory depression, and hypoxemia, were significantly lower in the R group compared to the P group. Conversely, the total number of phloroglucinol uses, body movements, and instances of rapid gastrointestinal peristalsis were significantly higher in the R group than in the P group. DiscussionRemimazolam-based MAC for ERCP exhibited non-inferior efficacy compared to propofol-based MAC, while also resulting in fewer circulatory and respiratory adverse events during the procedures. Nevertheless, future studies with larger sample sizes are required to evaluate the utility of remimazolam in elderly patients.

Comparing the effect of sedation with dexmedetomidine and propofol on sleep quality of patients after cardiac surgery: A randomized clinical trial.

Sleep quality is the main concern of patients after cardiac surgery. We compared the effect of two routinely used sedatives on the sleep quality of patients admitted to the intensive care unit (ICU) after cardiovascular surgery. It is a prospective, controlled, randomized clinical trial. A total of 120 patients, after cardiac surgery were enrolled. During extubating, patients were randomized into two groups: 60 patients received an infusion of dexmedetomidine (precede; 0.5 μg/kg/h), and 60 patients received 50 μg/kg/min propofol for 6 hours. Baseline characteristics were compared between the groups. The patients completed the St. Mary's Hospital Sleep Questionnaire, and the scores were compared between the groups. The groups were not different in terms of demographics, underlying diseases, smoking/drug abuse/alcohol, number of vessels involved, history of non-cardiac surgery, and mean levels of serum parameters (P>0.05). Most of the medications used were similar between the groups (P>0.05), except calcium channel blockers (more frequently used in the propofol group [P=0.027). The details of surgery were not statistically significant different (P>0.05); but, the mean volume of platelet received after the surgery was higher in propofol group (P=0.03). The propofol group had less problems with last night's sleep (0 vs 0.1±0.66), felt more clear-headed (4.9±0.6 vs 4.68±0.58, were more satisfied with their last night's sleep (52.1% vs 47.9%), but spent more time getting into sleep (0.38±1.67 vs 0 ) (P<0.5). The sleep quality of patients under the influence of propofol seemed to be better than dexmedetomidine after cardiac surgery.

Respiratory complications of propofol, sevoflurane, and dexmedetomidine anesthesia for fiberoptic bronchoscopy in children aged 1 month to 3 years: a randomized trial

To evaluate the effect of propofol, sevoflurane, and dexmedetomidine on respiratory complications in children undergoing fiberoptic bronchoscopy (FOB). This double-blind randomized clinical trial was conducted among 120 children aged 1 month to 3 years undergoing FOB. The patients were randomized into 3 groups (n=40) for anesthesia induction with sevoflurane inhalation, 1 mg/kg propofol, or 1 μg/kg dexmedetomidine before bronchoscopy, and the changes in hemodynamic parameters, sedation level, and respiratory complications during and after the procedure were assessed. The patients' heart rate during bronchoscopy was significantly lower and the mean arterial blood pressure significantly higher in dexmedetomidine group than in sevoflurane and propofol groups (P < 0.05). Cough during bronchoscopy did not occur in any of the cases in propofol group, while the highest frequency of cough was recorded in dexmedetomidine group. The incidence of laryngospasm in the propofol group (12.5%) was significantly lower than those in sevoflurane and dexmedetomidine groups (30% and 32.5%, respectively) (P < 0.05). Sevoflurane and propofol are safe and suitable for anesthesia induction in children below 3 years of age undergoing diagnostic FOB and can achieve better sedative effect and lower the incidences of cough and respiratory complications as compared with dexmedetomidine.

Unconscious classification of quantitative electroencephalogram features from propofol versus propofol combined with etomidate anesthesia using one-dimensional convolutional neural network.

Establishing a convolutional neural network model for the recognition of characteristic raw electroencephalogram (EEG) signals is crucial for monitoring consciousness levels and guiding anesthetic drug administration. This trial was conducted from December 2023 to March 2024. A total of 40 surgery patients were randomly divided into either a propofol group (1% propofol injection, 10 mL: 100 mg) (P group) or a propofol-etomidate combination group (1% propofol injection, 10 mL: 100 mg, and 0.2% etomidate injection, 10 mL: 20 mg, mixed at a 2:1 volume ratio) (EP group). In the P group, target-controlled infusion (TCI) was employed for sedation induction, with an initial effect site concentration set at 5-6 μg/mL. The EP group received an intravenous push with a dosage of 0.2 mL/kg. Six consciousness-related EEG features were extracted from both groups and analyzed using four prediction models: support vector machine (SVM), Gaussian Naive Bayes (GNB), artificial neural network (ANN), and one-dimensional convolutional neural network (1D CNN). The performance of the models was evaluated based on accuracy, precision, recall, and F1-score. The power spectral density (94%) and alpha/beta ratio (72%) demonstrated higher accuracy as indicators for assessing consciousness. The classification accuracy of the 1D CNN model for anesthesia-induced unconsciousness (97%) surpassed that of the SVM (83%), GNB (81%), and ANN (83%) models, with a significance level of p < 0.05. Furthermore, the mean and mean difference ± standard error of the primary power values for the EP and P groups during the induced period were as follows: delta (23.85 and 16.79, 7.055 ± 0.817, p < 0.001), theta (10.74 and 8.743, 1.995 ± 0.7045, p < 0.02), and total power (24.31 and 19.72, 4.588 ± 0.7107, p < 0.001). Large slow-wave oscillations, power spectral density, and the alpha/beta ratio are effective indicators of changes in consciousness during intravenous anesthesia with a propofol-etomidate combination. These indicators can aid anesthesiologists in evaluating the depth of anesthesia and adjusting dosages accordingly. The 1D CNN model, which incorporates consciousness-related EEG features, represents a promising tool for assessing the depth of anesthesia. https://www.chictr.org.cn/index.html.

A Comparison of the Use of Propofol versus Midazolam for Pediatric Magnetic Resonance Imaging Sedation: Retrospective Cohort Study.

The aim of the present study was to do a comparison of the recovery profiles and airway-related adverse events of pediatric magnetic resonance imaging (MRI) sedation patients who received propofol alone to those who received midazolam alone. This retrospective cohort study was approved by the Mutah University Ethical Approval Committee (No. 2378). A search of the patients' medical records was performed between September 2021 and April 2022 to identify children aged 4 months-11 years who received propofol or midazolam for MRI sedation. The patients were subdivided into two groups: Those who had propofol alone (propofol group) and those who received midazolam (midazolam group) for pediatric MRI sedation. In propofol group, a 1-2 mg/kg of propofol bolus was given to have a deep sedation (Ramsay Sedation Scale score of 5). Patients in midazolam group received 0.05 mg/kg of midazolam. During the maintenance state of sedation, the patient received 150 µg/kg/min of propofol, and the infusion rate was adjusted in 25 μg/kg/min increments up or down at the discretion of the anesthesiologists to maintain a state of deep sedation. The major targets of this study were recovery profiles (time to awake and time to discharge) and airway-related intervention ratios in pediatric MRI sedation patients. Patient demographics, MRI sedation, and recovery data, including propofol induction dose, airway intervention, and sedation-related adverse events from the pediatric sedation recovery unit were also collected. The mean (standard deviation [SD]) propofol induction dose was higher compared to midazolam group (2.4 [0.7] mg vs. 1.3 [0.5] mg; mean difference, 1.1 mg; P < 0.001). The mean (SD) infusion rate was higher in propofol group compared to midazolam group (161.3 [37.6] μg/min/kg vs. 116.2 [25.6] μg/min/kg; mean difference 45.1 μg/min/kg; P < 0.001). The mean (SD) propofol total dose was higher in propofol group compared to midazolam group (236.3 [102.4] mg vs. 180.7 [80.9] mg; mean difference, 155.4 mg; P < 0.001). The mean (SD) time to awake was longer in midazolam group compared to propofol group (21.2 [5.6] min vs. 23.0 [7.1] min; mean difference, 1.8 min; P < 0.001). The mean (SD) time to discharge was longer in midazolam group compared to propofol group (34.5 [6.9] min vs. 38.6 [9.4] min; mean difference, 4.1 min; 95% confidence interval, 3.0-5.1; P < 0.001). The administration of midazolam during pediatric MRI sedation can decrease the frequency of airway complications without prolonging the clinically significant recovery profile.