Target Sedation Level Research Articles

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).

Benefits of dexmedetomidine during noninvasive mechanical ventilation in major abdominal surgery patients with postoperative respiratory failure.

The efficacy of non-invasive mechanical ventilation (NIMV) on the postoperative ARF is conflicting and the failure rate of NIMV in this patient population is high. In our study, we hypothesized that the use of dexmedetomidine during NIMV in major abdominal surgical patients can reduce NIMV failure without significant side affect. Medical records of patients who underwent major abdominal surgery, admitted to our general surgery intensive care unit (ICU), developed postoperative ARF, received NIMV (with oro-nasal mask) and dexmedetomidine infusion were enrolled in this study. The infusion rate was adjusted to maintain a target sedation level of a Richmond Agitation-Sedation Scale (RASS) (-2)-(-3). The sedation was stopped when NIMV was discontinued. A total of 60 patients, 42 (70.0%) male, and 18 (30.0%) female, with a mean age of 68 ± 11 years were included in the study. The mean APACHE II score was 20 ± 6. Dexmedetomidine was infused for a median of 25 h (loading dose of 0.2 mcg/kg for 10 min, maintained at 0.2-0.7 mcg/kg/h, titrated every 30 min). RASS score of all study group significantly improved at the 2 h of dexmedetomidine initiation (+3 vs. -2, p = 0.01). A targeted sedation level was achieved in 92.5% of patients. Six (10.0%) patients developed bradycardia and 5 (8.3%) patients had hypotension. The mean NIMV application time was 23.4 ± 6.1 h. Seven (11.6%) patients experienced NIMV failure, all due to worsening pulmonary conditions, and required intubation and invasive ventilation. Fifty-three (88.3%) patients were successfully weaned from NIMV with dexmedetomidine sedation and discharged from ICU. The duration of NIMV application and ICU stay was shorter in NIMV succeded group (21.4 ± 3.2 vs. 29.9 ± 6.4; p = 0.012). Our study suggests that dexmedetomidine demonstrates effective sedation in patients with postoperative ARF during NIMV application after abdominal surgery. Dexmedetomidine can be considered safe and capable of improving NIMV success.

Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients: protocol for a prospective, single-center, randomized, double-blind, non-inferiority trial.

Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties when compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients. This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 patients aged 65years or older, who are scheduled for same-day bidirectional endoscopy under sedation, will be randomly allocated, in a 1:1 ratio, to either fospropofol group or propofol group (n = 128 in each group). All patients will receive analgesic pre-treatment with sufentanil 5μg. Two minutes later, an initial bolus dose of fospropofol 6.5mg/kg or 1.5mg/kg propofol and supplemental doses of fospropofol 1.6mg/kg or 0.5mg/kg propofol will be titrated as needed to achieve target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events concerning cough reflex, gag reflexes, body movement, muscular tremor, and pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in MBP ≥30% of baseline), and bradycardia, will also be recorded. Data will be analyzed on an intention-to-treat basis. We hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. Our findings will potentially provide a new sedation regimen for same-visit bidirectional endoscopy in elderly patients. clinicaltrials.gov, identifier NCT02875639.

Efficacy of ultrasound guided superior laryngeal nerve block on sedation for delayed extubation in maxillofacial surgery with free flap reconstruction

ObjectiveSuperior laryngeal nerve block (SLNB) is a regional anesthesia technique for addressing airway response. However, SLNB on the efficacy of sedation in patients with delayed extubation is unknown, particularly for maxillofacial surgery (MS). The aim of the study was to assess whether ultrasound guided (UG) SLNB reduces the incidence of moderate to severe cough for delayed extubation in MS with free flap reconstruction. Methods60 patients were randomly assigned to the GEA group (control group) and the SLNB group (UG-SLNB postoperatively, study group). During the initial two postoperative hours, the incidence of moderate and severe cough, agitation, and the number of patients requiring rescue propofol and flurbiprofen were recorded. Additionally, the time spent under the target level of sedation, postoperative hemodynamics, and the total does of propofol during the postoperative 24 h were recorded. ResultsThe data showed the SLNB group had a significantly lower incidence of moderate to severe cough and agitation (p < 0.05), and a longer sedation time (p < 0.05). The number of patients required rescue propofol and flurbiprofen, as well as the hemodynamic changes, were significantly different between the two groups (p < 0.05). ConclusionThe use of UG-SLNB is associated with reduced incidence of postoperative cough. Moreover, SLNB can enhance the efficacy of postoperative sedation with need of fewer agents postoperatively. Clinical Trial RegistrationChiCTR2000039982

Successful Use of Low-Dose Combination Propofol and Fentanyl in Cataract Surgery Phacoemulsification.

The combination between sedatives and opioids is one of the recommended anesthetic options in ophthalmic procedures and regimens are more advantageous as smaller amounts of each drug can be administered to reduce side effects and have proper outcomes due to the synergistic effects. This study aims to observe the use of low-dose propofol and fentanyl for patients undergoing phacoemulsification surgery. This observational study involves a sample of 125 adult patients who underwent elective cataract procedures using the phacoemulsification technique and had an American Society of Anesthesiologists (ASA) physical status of 1 to 3. Dose amount of fentanyl and propofol, Ramsay score, hemodynamic parameter, side effects, and patient satisfaction were evaluated, recorded, and analyzed using a 5-point Likert scale. The result showed the mean absolute dose of propofol was 12.46±4.376 mg, with a range between 10 and 30 mg, while the mean per body weight was 0.21±0.075 mg. Similarly, the mean absolute dose for fentanyl was 25.04±3.012 mcg within the range of 10-50 mcg, and the per-body weight dose was 0.43±0.080 mcg. About 90.4% and 9.6% of the patients reached Ramsay 2 and 3, respectively. The analysis of systolic, diastolic blood pressure, mean arterial pressure, and pulse rate showed that the combination of low-dose fentanyl and propofol was significantly lower than before therapy administration in all four values (p < 0.05). The combination of low-dose propofol and fentanyl in cataract surgery using phacoemulsification successfully reached the targeted sedation level and a significant decrease in blood pressure, MAP, pulse rate, minimal side effects, and high satisfaction rate.

Comparison of remimazolam and dexmedetomidine for intraoperative sedation in patients undergoing lower extremity surgery under spinal anesthesia: a randomized clinical trial

BackgroundDexmedetomidine sedation has advantages, such as low incidence of respiratory depression and prolonged block duration, but also significant disadvantages, such as slow onset, high rate of sedation failure, and a...

Dexmedetomidine versus haloperidol for sedation of non-intubated patients with hyperactive delirium during the night in a high dependency unit: study protocol for an open-label, parallel-group, randomized controlled trial (DEX-HD trial)

BackgroundDelirium is common in critically ill patients. Haloperidol has long been used for the treatment of delirium. Dexmedetomidine has recently been used to treat delirium among intubated critically ill patients. However, the efficacy of dexmedetomidine for delirium in non-intubated critically ill patients remains unknown. We hypothesize that dexmedetomidine is superior to haloperidol for sedation of patients with hyperactive delirium, and would reduce the prevalence of delirium among non-intubated patients after administration. We will conduct a randomized controlled trial to compare dexmedetomidine and haloperidol for the treatment of nocturnal hyperactive delirium in non-intubated patients in high dependency units (HDUs).MethodsThis is an open-label, parallel-group, randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for nocturnal hyperactive delirium in non-intubated patients at two HDUs of a tertiary hospital. We will recruit consecutive non-intubated patients who are admitted to the HDU from the emergency room, and allocate them in a 1:1 ratio to the dexmedetomidine or haloperidol group in advance. The allocated investigational drug will be administered only when participants develop hyperactive delirium (Richmond Agitation-Sedation Scale [RASS] score ≥1 and a positive score on the Confusion Assessment Method for the ICU between 19:00 and 6:00 the next day) during the night at an HDU. Dexmedetomidine is administered continuously, while haloperidol is administered intermittently. The primary outcome is the proportion of participants who achieve the targeted sedation level (RASS score of between -3 and 0) 2h after the administration of the investigational drug. Secondary outcomes include the sedation level and prevalence of delirium on the day following the administration of the investigational drugs, and safety. We plan to enroll 100 participants who develop nocturnal hyperactive delirium and receive one of the two investigational drugs.DiscussionThis is the first randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for sedation of non-intubated critically ill patients with hyperactive delirium in HDUs. The results of this study may confirm whether dexmedetomidine could be another option to sedate patients with hyperactive delirium.Trial registrationJapan Registry of Clinical Trials, jRCT1051220015, registered on 21 April 2022.

Efficacy and safety of remimazolam for procedural sedation during ultrasound-guided transversus abdominis plane block and rectus sheath block in patients undergoing abdominal tumor surgery: a single-center randomized controlled trial

BackgroundTo explore the efficacy and safety of remimazolam for procedural sedation during ultrasound-guided nerve block administration in patients undergoing abdominal tumor surgery, in order to improve and optimize remimazolam use in procedural sedation and clinical anesthesia.MethodsThe enrolled patients were randomly divided into three groups: 50 patients in the remimazolam group (R group), 50 patients in the dexmedetomidine group (D group), and 50 patients in the midazolam group (M group). Before administering an ultrasound-guided nerve block, all patients received sufentanil AND remimazolam or midazolam or dexmedetomidine. Remimazolam 5 mg was administered intravenously in group R, dexmedetomidine 0.6 µg/kg was administered intravenously in group D, and midazolam 0.025 mg/kg was administered intravenously in group M. Sedation was evaluated by the Modified Observer’s Assessment of Alertness and Sedation scale.When the Modified Observer’s Alertness/Sedation (MOAA/S) score was ≤ 2, block operation was started. If the target sedation level was not reached, rescue sedatives of remimazolam 2.5 mg may be intravenously given in group R, dexmedetomidine 0.4 µg/kg be intravenously given in group D, 0.01 mg/kg midazolam may be intravenously given in Group M. Hemodynamic indicators (systolic and diastolic blood pressure, heart rate), pulse oxygen saturation, depth of anesthesia (Narcotrend), MOAA/S,and the incidences of hypoxemia, injection pain, bradycardia and requirement for rescue sedatives were monitored and recorded.ResultsCompared with the control groups (midazolam and dexmedetomidine groups), the Narcotrend index and MOAA/S decreased more in the remimazolam group (P < 0.01). Compared with the control groups, the incidence of hypoxemia and injection pain was slightly higher in the remimazolam group, but the difference was not statistically significant (P > 0.05). Compared with the dexmedetomidine group, the incidence of bradycardia was significantly lower in the remimazolam group.ConclusionRemimazolam can be used safely for procedural sedation during ultrasound-guided nerve block administration in patients undergoing abdominal tumor surgery. The sedation effect is better than that with either midazolam or dexmedetomidine, and sedation can be achieved quickly without obvious hemodynamic fluctuations. Remimazolam is associated with better heart rate stability, and slightly higher incidences of hypoxemia and injection pain than are midazolam and dexmedetomidine (no statistically significant difference). The higher incidence of hypoxemia with remimazolam may be related to enhanced sufentanil opioid analgesia, and the mechanism of injection pain with remimazolam must be studied further and clarified.Trial registrationThis study was approved by the Ethics Committee of Anhui Provincial Cancer Hospital (Ethical Review 2021, No. 23) and registered at https://www.chictr.org.cn (ChiCTR2000035388). The pre-registration time of this experiment is 09/08/2020, due to ethical committee of the hospital met irregularly,the ethical approval time is 21/06/2021. The recruitment of patients began after the ethical approval (21/06/2021) and registration update (06/07/2021).The study protocol followed the CONSORT guidelines. The study protocol was performed in the relevant guidelines.

Prospective comparison of acupuncture with sham acupuncture to determine impact on sedation and analgesia in mechanically ventilated critically ill patients (PASSION study): protocol for a randomised controlled trial

IntroductionSedation and analgesia are recommended to be employed in the intensive care unit (ICU) to enhance patient comfort and safety, facilitate mechanical ventilation and reduce oxygen demands. However, the increasing...

Sequential use of midazolam and dexmedetomidine for long-term sedation may reduce weaning time in selected critically ill, mechanically ventilated patients: a randomized controlled study

BackgroundCurrent sedatives have different side effects in long-term sedation. The sequential use of midazolam and dexmedetomidine for prolonged sedation may have distinct advantages. We aimed to evaluate the efficacy and safety of the sequential use of midazolam and either dexmedetomidine or propofol, and the use of midazolam alone in selected critically ill, mechanically ventilated patients.MethodsThis single-center, randomized controlled study was conducted in medical and surgical ICUs in a tertiary, academic medical center. Patients enrolled in this study were critically ill, mechanically ventilated adult patients receiving midazolam, with anticipated mechanical ventilation for ≥ 72 h. They passed the spontaneous breathing trial (SBT) safety screen, underwent a 30-min-SBT without indication for extubation and continued to require sedation. Patients were randomized into group M-D (midazolam was switched to dexmedetomidine), group M-P (midazolam was switched to propofol), and group M (sedation with midazolam alone), and sedatives were titrated to achieve the targeted sedation range (RASS − 2 to 0).ResultsTotal 252 patients were enrolled. Patients in group M-D had an earlier recovery, faster extubation, and more percentage of time at the target sedation level than those in group M-P and group M (all P < 0.001). They also experienced less weaning time (25.0 h vs. 49.0 h; HR1.47, 95% CI 1.05 to 2.06; P = 0.025), and a lower incidence of delirium (19.5% vs. 43.8%, P = 0.002) than patients in group M. Recovery (P < 0.001), extubation (P < 0.001), and weaning time (P = 0.048) in group M-P were shorter than in group M, while the acquisition cost of sedative drug was more expensive than other groups (both P < 0.001). There was no significant difference in adverse events among these groups (all P > 0.05).ConclusionsThe sequential use of midazolam and dexmedetomidine was an effective and safe sedation strategy for long-term sedation and could provide clinically relevant benefits for selected critically ill, mechanically ventilated patients.Trial registrationNCT02528513. Registered August 19, 2015.

Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial.

BackgroundSame-visit bidirectional endoscopy (esophagogastroduodenoscopy and colonoscopy) is widely performed under sedation. At present, the optimal sedation regimen remains unclear. This study aims to test the hypothesis that a low-dose esketamine added to propofol sedation reduces hemodynamic and respiratory adverse events in these procedures.MethodsIn this multicenter, randomized, double-blind, placebo-controlled trial, 660 adult patients scheduled for same-visit bidirectional endoscopy under sedation from 3 teaching hospitals in China will be recruited. Patients will be randomly allocated, in a 1:1 ratio, to an esketamine group or a normal saline group (n = 330 in each group), stratified by study center. All patients will receive intravenous propofol 0.5 mg/kg and sufentanil 0.1 μg/mL for induction of sedation, followed by intravenous esketamine 0.15 mg/kg or the same volume of normal saline. Propofol will be titrated to the target sedation levels during the procedures. The primary endpoint is a composite of desaturation (peripheral oxygen saturation < 90%) and hypotension (systolic blood pressure <80 mmHg or decrease >30% of baseline). Secondary endpoints include desaturation, hypotension, total dose of propofol, pain scores and fatigue scores on the 0–10 numerical rating scale, dizziness or headache, hallucination or nightmare, nausea or vomiting, endoscopist satisfaction, and patient satisfaction. All analyses will be intention-to-treat.DiscussionWe expect that a low-dose esketamine adjunct to propofol-based sedation will improve cardiorespiratory stability in patients undergoing same-visit bidirectional endoscopy, providing reference for clinical sedation practice during these procedures.Trial RegistrationChinese Clinical Trial Registry (Identifier: ChiCTR-ChiCTR2200055938).

Gabapentin as Add-On to Fentanyl and Midazolam in Patients Receiving Mechanical Ventilation: A Randomized, Blinded Study.

Objective:Fentanyl and midazolam are popular drugs for sedation and analgesia in intensive care unit. Gabapentin has sedative and analgesic effects, as well. Our purpose was to study gabapentin addition to fentanyl and midazolam to reach the target sedation level in patients requiring mechanical ventilation.Methods:This was a randomized and double-blinded trial. Fifty patients receiving mechanical ventilation and aged from 18 to 70 years were randomized 1 : 1 to 300 mg gabapentin q8hr or placebo. The initial infusion rates of fentanyl and midazolam were 1-2 µg kg-1 h-1 and 0.06-0.2 mg kg-1 h-1, respectively, in both groups. Treatments continued prior to weaning. Ramsay sedation scale score (2-3) and behavioral pain scale score (≤4) were used for the evaluation of sedation and analgesia levels, respectively.Results:A total of 43 patients were studied. Both treatment modalities reached the target sedation and analgesia levels. In the intervention group, there were significant reductions in daily consumption of fentanyl and midazolam (P < .01). Duration of ventilation was shorter in the intervention group (4.1 ± 1.7 days vs 5.1 ± 1.3 days, P > .05). There was no significant difference in intensive care hospitalization, although it was shorter in the intervention group (201 ± 24 hours vs 224 ± 19 hours, P > .05).Conclusions:This trail showed that both treatment modalities could reach target sedation and analgesia levels without significant differences. Add-on therapy with gabapentin could reduce the total dose of fentanyl and midazolam.

Efficacy and Safety of Remimazolam Tosilate Combined With Esketamine for Analgesic Sedation in Mechanically Ventilated ICU Patients: A Single-Arm Clinical Study Protocol.

IntroductionPatients in the intensive care unit (ICU) frequently experience increased heart rate, blood pressure, and respiration rate as a product of anxiety and restlessness about their condition and treatments. Analgesia and sedation commonly involve benzodiazepines or opioids that lead to respiratory suppression and other adverse reactions. Remimazolam tosilate is a short-acting GABAA receptor agonist with reduced cardiovascular and respiratory inhibition compared to other commonly used benzodiazepines. Esketamine is a non-competitive N-methyl-D-aspartic acid (NMDA) receptor inhibitor that inhibits hyperalgesia and prolongs postoperative analgesia. It also reduces postoperative pain, delirium, and the use and acute tolerance of opioids. This study aims to assess the efficacy and safety of remimazolam tosilate combined with esketamine and sufentanil for sedation and analgesia in mechanically ventilated ICU patients.Methods and AnalysisThis prospective, single-arm, single-center, open-label clinical trial will be conducted from January 2022 to December 2023. The study will include 200 adult patients (≥ 18 years) from Shandong Provincial Hospital (affiliated with Shandong First Medical University) who are mechanically ventilated and admitted to the ICU between 24 and 72 h from the time of ventilation and who are administered analgesia and sedatives. Patients will undergo arterial blood gas analysis before administration. Remimazolam tosilate (0.2 mg/kg) will be injected intravenously within 30 s, followed by continuous infusion at a rate of 0.1 to 0.3 mg/kg/h via micropump. Esketamine (0.25 mg/kg) will be injected intravenously and maintained at 0.15 mg/kg/h, while sufentanil will be maintained at the rate of 0.1 to 0.2 μg/kg/h. The primary study outcome is the overall time required to maintain sedation. Secondary outcomes will include the total dosage used to reach the target sedation level, total mechanical ventilation time, awakening time, length of hospital stay, and incidence of cardiorespiratory-related adverse events and delirium. Adverse events (AEs) will be reported regardless of their relationship to the experimental drugs. AEs associated with adverse drug reactions will be classified as “affirmative correlation,” “possible relevance,” and “unable to determine.” A paired t-test or Wilcoxon signed-rank test will be used to compare the changes of observed indexes before and after treatment. A P < 0.05 will be considered statistically significant.Ethics and DisseminationThis study was approved by the local ethics committee at Shandong Provincial Hospital affiliatied to Shandong First Medical University. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.Trial RegistrationThe trial is registered at the Chinese Clinical Trial Registry: ChiCTR2100053106; date of registration: 2021-11-10.

Implementation of a sedation protocol: a quality improvement project to enhance sedation management in the paediatric intensive care unit

BackgroundProper sedation is integral to ensuring the safety and comfort of children on mechanical ventilation (MV). Sedation protocols help to achieve this goal and reduce the duration of MV. We...

Роль магнію в лікуванні стану відміни алкоголю з делірієм

Актуальність. На сьогодні роль магнію в лікуванні алкогольного делірію є невизначеною, хоча відомо про його участь в патогенезі цього тяжкого стану. Мета дослідження: виявлення переваг і недоліків седації з додаванням магнію сульфату порівняно зі стандартною седативною терапією. Матеріали та методи. Досліджено 40 пролікованих пацієнтів, які були рандомізовані на 2 групи. Рівень седації контролювався за Richmond agitation-sedation scale та утримувався в діапазоні від 0 до –2 балів. У всіх групах оцінювалися параметри: тривалість делірію, середній артеріальний тиск (САТ), пульс, магній, кортизол і серотонін плазми, лабораторні показники стану нирок і печінки. У контрольній групі проводилася седація 10–20 мг діазепаму кожні 4–6 годин з інфузією барбітуратів при необхідності. У дослідній групі лікування було ідентичним із додаванням магнію сульфату 50 мг/кг кожні 8 годин. Результати. Тривалість делірію була вірогідно нижчою в дослідній групі порівняно з контролем, p &lt; 0,05. Гіпомагніємію виявлено майже в половини пацієнтів. При порівнянні показників гемодинаміки виявлено вірогідне зниження САТ та частоти серцевих скорочень на третій день в обох групах, p &lt; 0,05. У дослідній групі виявлено 4 випадки (20 %) гіпотонії, у контрольній групі — 2 випадки (10 %). При дослідженні динаміки кортизолу та серотоніну виявлено вірогідну різницю на третій день в обох групах, p &lt; 0,05. Вірогідної різниці в цих показниках на третій день між групами не виявлено, p ≥ 0,05. Лабораторні показники стану печінки та нирок в обох групах не відрізнялися, p ≥ 0,05. Висновки. Використання магнію сульфату дозволяє зменшити тривалість делірію, але має надлишковий вплив на гемодинаміку. Ефект магнезії не верифікується такими біомаркерами, як кортизол і серотонін.

Experience of Dexmedetomidine using for intraoperative analgosedation during ophthalmic operations

Background. The aim of the study is to evaluate the quality and safety of the sedative effect of anesthesia in ambulant ophthalmic surgery by using continuous intravenous infu­sion of Dexmedetomidine. Materials and Methods. Patients were randomized into groups by age (people from 65 to 75 years old, old age 76 years, middle age, young people, children), by gender (men, women). The physical status of patients was assessed using the ASA scale and the dynamics of vegetatic activity by the Kerdo index. Sedation was assessed using the Richmond Sedation Scale RASS.Results. It was found that the difference in the frequency of adverse effects of the appointment of Dexmedetomidine clearly confirms the need to adjust the dose of Dexmede­tomidine, depending on the state of the autonomic nervous system. The use of Dexmedetomidine according to the rec­ommendations made it possible to achieve a safe level of sedation and eliminate side effects in ambulant ophthalmic surgery.Conclusions:&#x0D; &#x0D; Parenteral continuous infusion of Dexmedetomidine pro­vides an effective level of sedation for ambulant ophthalmic surgery and maintaining patient­surgeon contact.&#x0D; Safety is confirmed by a low level of critical incidents, no respiratory depression at the target sedation level.&#x0D; The patency of the upper airways was better compared to previous experience with propofol.&#x0D;

Responsiveness Index versus the RASS-Based Method for Adjusting Sedation in Critically Ill Patients.

Background Sedation of intensive care patients is needed for patient safety, but deep sedation is associated with adverse outcomes. Frontal electromyogram-based Responsiveness Index (RI) aims to quantify the level of sedation and is scaled 0–100 (low index indicates deep sedation). We compared RI-based sedation to Richmond Agitation-Sedation Scale- (RASS-) based sedation. Our hypothesis was that RI-controlled sedation would be associated with increased total time alive without mechanical ventilation at 30 days without an increased number of adverse events. Methods 32 critically ill adult patients with mechanical ventilation and administration of sedation were randomized to either RI- or RASS-guided sedation. Patients received propofol and oxycodone, if possible. The following standardized sedation protocol was utilized in both groups to achieve the predetermined target sedation level: either RI 40–80 (RI group) or RASS −3 to 0 (RASS group). RI measurement was blinded in the RASS group, and the RI group was blinded to RASS assessments. State Entropy (SE) values were registered in both groups. Results RI and RASS groups did not differ in total time alive in 30 days without mechanical ventilation (p=0.72). The incidence of at least one sedation-related adverse event did not differ between the groups. Hypertension was more common in the RI group (p=0.01). RI group patients were in the target RI level 22% of the time and RASS group patients had 57% of scores within the target RASS level. The RI group spent significantly more time in their target sedation level than the RASS group spent in the corresponding RI level (p=0.03). No difference was observed between the groups (p=0.13) in the corresponding analysis for RASS. Propofol and oxycodone were administered at higher RI and SE values and lower RASS values in the RI group than in the RASS group. Conclusion Further studies with a larger sample size are warranted to scrutinize the optimal RI level during different phases of critical illness.

Dexmedetomidine use and mortality in mechanically ventilated patients with severe burns: A cohort study using a national inpatient database in Japan

BackgroundDexmedetomidine is an alpha 2-adrenergic receptor agonist. Apart from its sedative effects, dexmedetomidine can potentially reduce mortality through its anti-inflammatory effect. However, the impact of dexmedetomidine on in-hospital outcomes of patients with severe burns remains unclear. Therefore, we aimed to elucidate the association between dexmedetomidine use and mortality in mechanically ventilated patients with severe burns, using a Japanese nationwide database of in-hospital patients. MethodsWe included adults with severe burns (burn index ≥ 10) who were registered in the Japanese Diagnosis Procedure Combination national inpatient database from 2010 to 2018, started mechanical ventilation within 3 days of admission, and received any sedative drug (dexmedetomidine, midazolam, or propofol). One-to-one propensity score matching was performed between patients who received dexmedetomidine on the day of mechanical ventilation initiation (dexmedetomidine group) and those who did not receive dexmedetomidine (control group). The primary outcome was all-cause 30-day in-hospital mortality. Secondary outcomes were length of hospital stay and duration of mechanical ventilation in patients and survivors. ResultsEligible patients (n = 1888) were classified into the dexmedetomidine group (n = 371) or the control group (n = 1517). After one-to-one propensity score matching, we compared 329 patients from both groups. No significant difference was observed in the 30-day mortality between patients in the dexmedetomidine and control groups (22.8% vs. 22.5%, respectively; odds ratio, 1.02; 95% confidence interval, 0.71–1.46). Moreover, there were no significant differences between patients in the dexmedetomidine and control groups in terms of the length of hospital stay or the duration of mechanical ventilation. ConclusionsWe found no significant association between dexmedetomidine use and in-hospital outcomes (mortality, length of hospital stay, and length of mechanical ventilation) in mechanically ventilated patients with severe burns. Dexmedetomidine use may not improve the aforementioned outcomes; therefore, its selection should be based on the patient’s general condition and the target level of sedation.

Cerebral oximetry monitoring in non-intubated patients undergoing endoscopic retrograde cholangiopancreatography under propofol-induced sedation: a prospective observational study.

BackgroundProlonged propofol-induced deep sedation increases the risk for sedation-related complications. Cerebral oximetry enables prompt assessment of tissue oxygenation by demonstrating the regional hemoglobin oxygen saturation (rSO2) of the cerebral cortex. This study aimed to: evaluate cerebral oxygenation under deep sedation during an endoscopic retrograde cholangiopancreatography (ERCP) procedure; determine the cerebral desaturation event (CDE) rate; and assess the predictive capacity of CDEs for sedation-related complications.MethodsAll consecutive patients who underwent ERCP between September and December 2019 were included prospectively. Propofol monotherapy was used and sedation level was assessed using the bispectral index (BIS). The target level of sedation was deep sedation, defined by BIS values 40-60. Participants were monitored with arterial blood gas analysis and INVOS 5100C cerebral oximeter. RSO2 values were registered prior to sedation (baseline value), every 5 min during the sedation period and at recovery of consciousness. BIS values were recorded simultaneously. CDE was defined as a drop >10% from individual baseline rSO2.ResultsSixty patients were enrolled. Mean baseline rSO2 was 65.1% and BIS values ranged from 18-85. No significant correlation was observed between mean rSO2 measurements and mean BIS values throughout the recordings (P = 0.193). Data from patients aged ≥65 years were analyzed separately and the results were similar. The CDE rate was 2.7%, but no CDE was associated with clinical manifestations. Twelve sedation-related complications occurred without the presence of cerebral desaturation.ConclusionCerebral oxygenation remained independent of changes in sedation depth and cerebral oximetry monitoring did not detect complications earlier than standard monitors.

Dexmedetomidine in modern anesthesiology and intensive care

Background. Sedation is a controlled medical depression of consciousness with the preservation of protective reflexes, independent effective breathing and response to physical stimulation and verbal commands. Sedation is indicated for patients in the intensive care unit in presence of agitation, delirium, withdrawal syndrome of alcohol, drugs or other potent medications and the need to protect the brain (blunt traumatic brain injury, posthypoxic encephalopathy). In addition, at the request of the patient, sedation can be used during invasive diagnostic and treatment procedures.&#x0D; Objective. To describe the role of dexmedetomidine in modern anesthesiology and intensive care.&#x0D; Materials and methods. Analysis of literature data on this issue.&#x0D; Results and discussion. When performing sedation, one should balance between the excessive sedation and its absence. Excessive sedation is accompanied by the lack of contact with the patient, inability to assess the neurological status of the patient, and respiratory depression. If the patient is optimally sedated, he is calm and able to cooperate; he is also adapted to mechanical lung ventilation and other procedures. The target level of sedation according to the Richmond excitation-sedation scale is from 0 to -1. Drugs such as benzodiazepines (diazepam, midazolam, lorazepam), barbiturates (sodium thiopental), propofol, ketamine, inhaled anesthetics (sevoflurane, dexflurane), dexmedetomidine, opioids (morphine, fentanyl, remifentanyl) are used for sedation. Dexmedetomidine is a highly selective α2-adrenoagonist, so it has anxiolytic, sedative, antinociceptive, sympatholytic, and hypothermic actions. In addition, this drug reduces heart rate, suppresses tremor and increases diuresis. The sedative effect of dexmedetomidine is due to the inhibition of neuronal activity in the locus coeruleus of the brain stem. The condition caused by dexmedetomidine is similar to the natural sleep. The use of dexmedetomidine allows to achieve the target level of sedation in a higher percentage of cases than the use of other drugs (propofol, midazolam) (Jacub S.M. et al., 2012). Cooperative sedation is a sedation with the possibility of interaction of the patient with the medical staff. Compared to other drugs, dexmedetomidine increases the patient’s ability to wake up and quickly orient, after which the patient can quickly return to a state of sedation. One of the major complications of critically serious diseases and their treatment is the deterioration of cognitive abilities. Dexmedetomidine has been shown to improve the patient’s cognitive performance by 6.8 points on the John Hopkins scale. In contrast, propofol reduces cognitive function by an average of 12.4 points (Mirski M.A. et al., 2010). Dexmedetomidine has no respiratory depressant effect. Patients on mechanical ventilation do not require discontinuation of dexmedetomidine prior to extubation. Importantly, dexmedetomidine increases coronary blood flow, reduces the incidence of perioperative myocardial ischemia and the risk of perioperative cardiac death. Dexmedetomidine reduces the intensity of pain in the postoperative period and the need for opioids, the incidence of delirium, and the duration of mechanical ventilation. The financial and economic reasonability of dexmedetomidine use has been proved.&#x0D; Conclusions. 1. Sedation is indicated for patients in the intensive care unit in presence of agitation, delirium, withdrawal syndrome and the need to protect the brain, as well as during invasive diagnostic and treatment procedures. 2. The target level of sedation is from 0 to -1 on the Richmond excitation-sedation scale. 3. Dexmedetomidine is a highly selective α2-adrenoagonist, which has anxiolytic, sedative, antinociceptive, sympatholytic, and hypothermic action. 4. Dexmedetomidine increases coronary blood flow and reduces the incidence of perioperative myocardial ischemia, the risk of perioperative cardiac death, pain, delirium incidence and the duration of mechanical ventilation.