Alfentanil-Propofol Versus Sufentanil-Propofol Sedation on Postoperative Fatigue After Gastrointestinal Endoscopy: A Multicenter Randomized Control Trial.
Opioid-propofol sedation is standard for gastrointestinal endoscopy but may contribute to postoperative fatigue (POF). This study compared the severity of POF between sufentanil-propofol and alfentanil-propofol sedation in patients undergoing gastrointestinal endoscopy. In this randomized trial, 248 patients scheduled for esophagogastroduodenoscopy and/or colonoscopy received either alfentanil (7.5-10μg/kg) or sufentanil (0.1-0.2μg/kg) combined with propofol for deep sedation. The primary outcome was POF severity assessed by the Christensen Fatigue Scale (CFS) 30min post-procedure. Secondary outcomes included recovery times (awakening and ambulation), incidence of clinically significant fatigue (CFS ≥ 6), and adverse events. At 30min post-procedure, the alfentanil group had significantly lower CFS scores than the sufentanil group (mean [standard deviation, SD]: 4.7 [1.0] vs. 5.7 [1.0]; mean difference -1.1, 95% CI -1.3 to -0.8; P < 0.001). The proportion of patients with CFS score ≥ 6 was also lower in the alfentanil group (20.8% vs. 35.7%, P = 0.004). Recovery was faster in the alfentanil group for both awakening (3.0 [2.2] vs. 5.5 [2.8] minutes, P < 0.001) and ambulation (12.8 [2.4] vs. 15.7 [3.4] minutes, P < 0.001). Adverse events including dizziness, nausea, and vomiting were less frequent with alfentanil (15.2% vs. 26.0%, P = 0.035; and 4.8% vs. 12.2%, P = 0.036). Compared to sufentanil, alfentanil combined with propofol significantly reduced postoperative fatigue and enhanced recovery in patients undergoing deeply sedated gastrointestinal endoscopy. Name of trial registry: Chinese Clinical Trial Registry. ChiCTR2300071429. URL: https://www.chictr.org.cn/showproj.html?proj=186791.
- Research Article
6
- 10.1007/s11096-024-01774-2
- Jul 31, 2024
- International journal of clinical pharmacy
Remimazolam tosilate is a new type of benzodiazepine currently used for gastrointestinal endoscopy and can be combined with alfentanil. This trial compared the effectiveness and safety of remimazolam with alfentanil to propofol with alfentanil in patients undergoing gastrointestinal endoscopy. One hundred and sixty-six patients were randomly divided into propofol-alfentanil anaesthesia (Group P) and remimazolam-alfentanil anaesthesia (Group R). The primary outcomes were perioperative haemodynamic variables, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) and oxygen saturation (SpO2) preoperatively (T0); after anaesthesia induction (T1); when the gastroscope passed through the oropharynx (T2); 3min (T3), 5min (T4) and 7min (T5) after T2; at the end of surgery (T6); and when patients successfully awakened (T7). The secondary outcomes included induction and awakening time, patient satisfaction, operator satisfaction, and adverse event occurrences. Compared with those in Group P, the SBP in Group R was significantly higher at T1, T2, T3, and T6 (P < 0.05); the DBP and MAP were significantly higher at T1, T2, T3, T5, and T6 (P < 0.05); the HR was significantly faster at T1 to T6 (P < 0.05); the SpO2 was significantly higher at T1 to T4 (P < 0.05); the incidences of hypoxemia, hypotension, and drug injection pain were significantly lower in Group R (P < 0.05); the incidence of hiccups was higher (P < 0.05); the awakening time was shorter in Group R (P < 0.05); and the operator satisfaction score was high (P < 0.05). Compared to propofol with alfentanil, remimazolam with alfentanil can be used safely and effectively for sedation in patients undergoing gastrointestinal endoscopy, with less impact on the patient's circulatory and respiratory systems and a lower incidence of adverse events. This trial protocol was registered in the Chinese Clinical Trial Registry (ChiCR2300077252, date: 2023-11-02).
- Research Article
11
- 10.1186/s12871-024-02475-z
- Mar 9, 2024
- BMC Anesthesiology
BackgroundCurative endoscopic resection is widely used to treat colonic polyps and early stage cancers. The anesthetic strategy commonly involves the use of propofol combined with a small dose of opioids for sedation. Adverse respiratory or cardiovascular events such as hypotension often occur when attempting to achieve the necessary level of sedation. Several studies have suggested its advantages owing to the anesthetic, analgesic, and sympathomimetic properties of esketamine. However, there are no reports on curative colorectal endoscopic resection. We designed this randomized controlled trial to assess the efficacy and safety of esketamine combined with propofol for sedation in patients undergoing curative colorectal endoscopic resection.MethodsA total of 166 patients who underwent curative colorectal endoscopic resection were randomly assigned to groups A (propofol + fentanyl) or E (propofol + esketamine). Ideal sedation was assessed using the MOAA/S scale and was achieved using TCI-propofol with different doses of fentanyl and esketamine. The propofol consumption and vasoactive drug dosages were recorded. Sedation-related times, adverse events, and satisfaction were recorded.ResultsOf the 160 patients, the total propofol consumption was significantly lower in group E (n = 81) (300 mg) than in group A (n = 79) (350 mg). Hypotension and bradycardia were significantly lower in Group E than in Group A. The groups showed no significant differences in other adverse events, induction time, recovery time, or patient or endoscopist satisfaction.ConclusionCompared to fentanyl, esketamine helps decrease propofol consumption and increases cardiovascular stability during curative colorectal endoscopic resection in American Society of Anesthesiologists Class I–III patients without affecting anesthesia, patient and endoscopist satisfaction, or other adverse events.Trial registrationThe study was retrospectively registered at the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number: ChiCTR2300069014 on 03/03/2023).
- Research Article
3
- 10.4103/aam.aam_109_23
- Sep 14, 2024
- Annals of African medicine
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.
- Front Matter
22
- 10.1016/j.gie.2009.01.029
- Jul 23, 2009
- Gastrointestinal Endoscopy
Toward safer sedation in patients with cirrhosis: have we done enough?
- Research Article
9
- 10.1186/s13063-023-07208-0
- Mar 15, 2023
- Trials
BackgroundHypoxia is a very common adverse event that occurs during gastrointestinal endoscopy under sedation, especially in older patients, owing to limited reservation of heart, brain, lung, and other organs. Prolonged or severe hypoxia can cause ischemia of the coronary artery and permanent nervous system damage, and even result in death. Hence, it is imperative to reduce or prevent hypoxia during gastrointestinal endoscopy under sedation in older patients. Although several oxygen delivery methods would reduce hypoxia during this procedure, early detection of respiratory depression and early administration of intervention would be the best method to reduce or even confirm the hypoxia. Capnographic monitoring is reportedly more sensitive for detecting respiratory depression before the onset of hypoxia than the current clinical routine monitoring of pulse oxygen saturation; however, its effect is controversial. Therefore, in this study, we aimed to improve the safety of gastrointestinal endoscopy under sedation in older patients.MethodsA multicenter, randomized, single-blind, two-arm parallel-group, controlled with an active comparator, interventional superiority clinical trial will be conducted to evaluate the impact of an additional capnographic monitoring-based intervention on the incidence of hypoxia in older patients. Patients (n = 1800) scheduled for gastrointestinal endoscopy with propofol sedation will be randomly assigned to either a control or interventional arm, wherein standard or capnographic monitoring is implemented, respectively.DiscussionThis study primarily aims to examine whether an additional capnographic monitoring-based intervention can reduce the incidence of hypoxia in older patients during gastrointestinal endoscopy under propofol and sufentanil sedation. The results of this study may extensively impact gastrointestinal endoscopy under sedation and the development of associated guidelines.Trial registrationClinicalTrials.gov NCT05030870. Registered on September 1, 2021.
- Research Article
6
- 10.3390/jcm12185959
- Sep 14, 2023
- Journal of Clinical Medicine
Endoscopic procedures are routinely applied to cancer screening programs and surveillance. The preferred technique is usually deep sedation with propofol being a convenient agent allowing for a quicker patient recovery while maintaining a similar safety profile compared to traditional agents. However, adverse events, including respiratory depression and consequent undesirable cardiovascular side effects, may occur. The goal of this work is to evaluate the patient safety impact of adding capnography during endoscopic procedures under deep propofol sedation. Data were retrospectively collected from patients undergoing deep, procedural sedation for gastrointestinal (GI) endoscopy in October 2019 to January 2021 in a single Turkish university hospital. Included in the analysis were all adult patients classified by the American Society of Anesthesiologists (ASA) as I–IV, who were scheduled for GI endoscopy utilizing propofol alone or in combination. Data on 1840 patients were collected, of whom 1610 (730 pre- and 880 post-capnography implemention) met inclusion criteria. The primary outcome was a change in the composite incidence of mild oxygen desaturation (SpO2 75–90% for <60 s), severe oxygen desaturation (SpO2 < 75% anytime or <90% for >60 s), bradycardia (<60 ppm), and tachycardia (>25% from baseline). Without capnography, on average, 7.5 events of the primary endpoint were observed per 100 procedures and 2.9 with additional capnography monitoring (p < 0.001). A significant reduction was observed for mild oxygen desaturation, with a resulting odds ratio of 0.25 (95% CI 0.14 to 0.46). ASA I patients had the highest difference in combined incidence of any oxygen desaturation of 5.85% in the pre-capnography group and 0.64% in the post-capnography group. Although procedural sedation using propofol is not associated with severe adverse events, the incidence of composite adverse events could be reduced with the addition of capnography monitoring.
- Research Article
1
- 10.1177/08971900221131420
- Oct 2, 2022
- Journal of Pharmacy Practice
Purpose: The optimal agent for deep sedation in patients undergoing continuous infusion (CI) neuromuscular blocking agent (NMBA) use for acute respiratory distress syndrome (ARDS) is unknown. The purpose of this study is to compare the efficacy and safety of propofol and midazolam in ARDS patients requiring CI NMBA. Methods: A multi-center, retrospective study was performed in mechanically ventilated (MV) adult patients requiring CI NMBA for management of ARDS. The primary outcome was to compare the time to liberation from MV in patients sedated with propofol vs midazolam. Results: In the 109 patients included, there was no difference in time to MV liberation with propofol as compared to midazolam (121 hr [Interquartile range (IQR) 67 195] vs 98 hr [IQR 48, 292], P = .72). Median time to sedation emergence after NMBA discontinuation was shorter in patients receiving propofol (12.9 hr [IQR 19.8, 72.5] vs 31.5 hr [IQR 6.4, 34.6], P < .01). There were no significant differences in time to therapeutic sedation, ICU stay, mortality, and adverse events. Conclusion: Propofol may be an effective and safe alternative to midazolam for patients undergoing CI NMBA for ARDS. Additionally, patients receiving propofol may have a quicker return to light sedation after NMBA discontinuation.
- Discussion
5
- 10.5946/ce.2016.49.1.1
- Jan 1, 2016
- Clinical Endoscopy
See the article "Considerable Variability of Procedural Sedation and Analgesia Practices for Gastrointestinal Endoscopic Procedures in Europe" in Volume 49 on page 47.
- Research Article
1
- 10.1016/j.dld.2024.11.029
- Jun 1, 2025
- Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
Deep sedation for gastrointestinal endoscopy in elderly patients. Subgroup analysis.
- Research Article
51
- 10.1007/s10620-010-1308-0
- Jul 16, 2010
- Digestive Diseases and Sciences
The purposes of this study are: (1) to prospectively evaluate clinically relevant outcomes including sedation-related complications for endoscopic ultrasound (EUS) procedures performed with the use of propofol deep sedation administered by monitored anesthesia care (MAC), and (2) to compare these results with a historical case-control cohort of EUS procedures performed using moderate sedation provided by the gastrointestinal (GI) endoscopist. Patients referred for EUS between January 1, 2001 and December 31, 2002 were enrolled. Complication rates for EUS using MAC sedation were observed and also compared with a historical case-control cohort of EUS patients who received meperidine/midazolam for moderate sedation, administered by the GI endoscopist. Logistic regression analysis was used to isolate possible predictors of complications. A total of 1,000 patients underwent EUS with propofol sedation during the period from January 1, 2001 through December 31, 2002 (mean age 64 years, 53% female). The distribution of EUS indications based on the primary area of interest was: 170 gastroduodenal, 92 anorectal, 508 pancreaticohepatobiliary, 183 esophageal, and 47 mediastinal. The primary endpoint of the study was development of sedation-related complications occurring during a performed procedure. A total of six patients experienced complications: duodenal perforation (one), hypotension (one), aspiration pneumonia (one), and apnea requiring endotracheal intubation (three). The complication rate with propofol was 0.60%, compared with 1% for the historical case-control (meperidine/midazolam moderate sedation) group. There does not appear to be a significant difference between complication rates for propofol deep sedation with MAC and meperidine/midazolam administered for moderate sedation.
- Research Article
4
- 10.2147/dddt.s490423
- May 1, 2025
- Drug design, development and therapy
Propofol and sufentanil are the most commonly used anesthetics during bronchoscopy. Esketamine is an s-enantiomer of ketamine racemate and has both sedative and analgesic effects, it does not inhibit respiration and maintains hemodynamic stability. We aimed to compare the intraoperative hypoxemia risk of esketamine/propofol with sufentanil/propofol for patients in bronchoscopy. This study was an investigator-initiated, single-center, randomized, double-blind clinical trial. Patients undergoing bronchoscopy were randomly assigned to receive either sufentanil group (n = 33; sufentanil: 0.2μg/kg) or esketamine group (n = 33; esketamine: 0.2 mg/kg) for sedation and analgesia. Clinical data, anesthetics usage, incidence of intraoperative hypoxemia, total time of hypoxemia, recovery time, and adverse events were recorded. The incidence of intraoperative hypoxemia was significantly lower in the esketamine group than in the sufentanil group (27.2% vs 66.7%, P=0.001, OR=5.333, 95% CI=1.859-15.301). Propofol usage was significantly higher in the esketamine group than in the sufentanil group (t=2.952, P=0.004). The duration of hypoxia was significantly lower in the esketamine group than in the sufentanil group (Z=-3.445, P<0.001), and the minimum oxygen saturation (SpO2) was significantly higher than in the sufentanil group (Z=-2.682, P=0.007). Recovery time from anesthesia was significantly lower in the esketamine group than in the sufentanil group (Z=-2.709, P=0.007). No difference was found in adverse reactions between the two groups. Esketamine combined with propofol reduced the incidence of intraoperative hypoxemia compared with sufentanil in bronchoscopy. Our results offer the possibility for a novel recommendation for the prevention of intraoperative hypoxemia during bronchoscopy. However, we mentioned the higher propofol use in the esketamine group. Additional clarification is necessary on the indications and the optimal dose of esketamine. Chinese clinical trial registry: ChiCTR2200058990.
- Research Article
16
- 10.1186/s12871-022-01630-8
- Mar 28, 2022
- BMC Anesthesiology
BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic procedure and requires deep sedation. Deep sedation with dexmedetomidine for the respiratory drive preserved has become popular in recent years. However, the use of dexmedetomidine in elderly patients is controversial because its adverse events are more common. The objective of this study was to investigate the effectiveness of a single loading dose of dexmedetomidine combined with propofol for deep sedation of ERCP in elderly patients.MethodsIn this prospective randomized trial, 49 elderly patients undergoing ERCP were randomly allocated to the dexmedetomidine (DEX) or propofol (PRO) groups. The single loading dose of dexmedetomidine was set at 0.5 μg/kg at the start of anesthesia induction and loading for 10 min. The primary outcome was the cumulative dose of propofol. Secondary outcomes included time to awake, the frequency of airway interventions, and hemodynamics.ResultsThe intraoperative cumulative dose of propofol was lower in the DEX group (111.0 ± 12.6 μg/kg/min) than the PRO group (143.7 ± 23.4 μg/kg/min) (P < 0.001). There was no statistically significant difference in the time to awake between the two groups. The incidence of artificial airway interventions and hypotension in the PRO group (36%, 60%) were significantly higher than those in the DEX group (4.2%, 16.7%) (P = 0.011, P = 0.003, respectively). In addition, the occurrence of bradycardia increased significantly in the DEX group (58.3%) compared with the PRO group (12%) (P < 0.001).ConclusionsThe single loading dose of dexmedetomidine combined with propofol can reduce propofol consumption and artificial airway intervention and provide better hemodynamic stability than propofol for deep sedation in elderly patients during ERCP.Trial registrationwww.chictr.org.cn (Registration number ChiCTR1900028069, Registration date 10/12/2019).
- Research Article
- 10.7759/cureus.102433
- Jan 27, 2026
- Cureus
Propofol is the cornerstone sedative for gastrointestinal (GI) endoscopy but is associated with dose-dependent cardiorespiratory depression. Remimazolam, a novel ultrashort-acting benzodiazepine with a specific antagonist (flumazenil), may offer a safer profile. This meta-analysis aimed to compare the efficacy and safety of remimazolam versus propofol for sedation in adult patients undergoing GI endoscopic procedures. We systematically searched PubMed, Web of Science, EMBASE, and the Cochrane Library from inception to January 5, 2026. Randomized controlled trials (RCTs) comparing intravenous remimazolam with propofol for sedation during GI endoscopy were included. The primary outcome was the incidence of a composite of cardiorespiratory adverse events (hypotension, respiratory depression/hypoxemia, bradycardia). Secondary outcomes included sedation success rate, recovery times, and patient/physician satisfaction. Risk of bias (RoB) was assessed using the Cochrane RoB 2 tool. Data were pooled using a random-effects model. Heterogeneity was quantified by I². 14 RCTs (n=2,883 patients) were included. Remimazolam significantly reduced the risk of the composite cardiorespiratory adverse event compared to propofol (risk ratio (RR) = 0.34, 95% confidence interval (CI): 0.27-0.44; I² = 56%). Sedation success rates were comparable between groups. Recovery profiles were similar or favorable for remimazolam in several studies, and it was associated with significantly less injection pain and higher patient satisfaction in some trials. Remimazolam offers a superior safety profile regarding cardiorespiratory stability compared to propofol for sedation in GI endoscopy, while maintaining non-inferior efficacy. These findings support remimazolam as a valuable alternative, especially for patients at higher risk of sedation-related complications.
- Research Article
16
- 10.2147/dddt.s464518
- May 1, 2024
- Drug design, development and therapy
Oxycodone is a potent μ- and κ-opioid receptor agonist that can relieve both somatic and visceral pain. We assessed oxycodone- vs sufentanil-based multimodal analgesia on postoperative pain following major laparoscopic gastrointestinal surgery. In this randomised double-blind controlled trial, 40 adult patients were randomised (1:1, stratified by type of surgery) to receive oxycodone- or sufentanil-based multimodal analgesia, comprising bilateral transverse abdominis plane blocks, intraoperative dexmedetomidine infusion, flurbiprofen axetil, and oxycodone- or sufentanil-based patient-controlled analgesia. The co-primary outcomes were time-weighted average (TWA) of visceral pain (defined as intra-abdominal deep and dull pain) at rest and on coughing during 0-24 h postoperatively, assessed using the numerical rating scale (0-10) with a minimal clinically important difference of 1. All patients completed the study (median age, 64 years; 65% male) and had adequate postoperative pain control. The mean (SD) 24-h TWA of visceral pain at rest was 1.40 (0.77) in the oxycodone group vs 2.00 (0.98) in the sufentanil group (mean difference=-0.60, 95% CI, -1.16 to -0.03; P=0.039). Patients in the oxycodone group had a significantly lower 24-h TWA of visceral pain on coughing (2.00 [0.83] vs 2.98 [1.26]; mean difference=-0.98, 95% CI, -1.66 to -0.30; P=0.006). In the subgroup analyses, the treatment effect of oxycodone vs sufentanil on the co-primary outcomes did not differ in terms of age (18-65 years or >65 years), sex (female or male), or type of surgery (colorectal or gastric). Secondary outcomes (24-h TWA of incisional and shoulder pain, postoperative analgesic usage, rescue analgesia, adverse events, and patient satisfaction) were comparable between groups. For patients undergoing major laparoscopic gastrointestinal surgery, oxycodone-based multimodal analgesia reduced postoperative visceral pain in a statistically significant but not clinically important manner. Chinese Clinical Trial Registry (ChiCTR2100052085).
- Research Article
- 10.1097/aln.0000000000005821
- Nov 7, 2025
- Anesthesiology
Background:Breast cancer surgery is often associated with unpleasant postoperative symptoms, including pain, nausea, fatigue, and emotional distress, which can reduce quality of life and prolong recovery times. This study aimed to test the efficacy of preoperative hypnosis in reducing postoperative symptoms after breast cancer surgery.Methods:A total of 203 women scheduled for breast cancer surgery at Oslo University Hospital in Oslo, Norway, participated in a randomized controlled trial. Patients were randomized to receive a single session of either preoperative hypnosis or mindfulness within 2 h before their scheduled surgery. Primary outcomes were postoperative pain, fatigue, nausea, discomfort, and emotional distress, measured using 100-mm visual analog scales on the day of surgery after recovery from general anesthesia. Additional measures included amount of intraoperative and postoperative anesthesia and analgesia, as well as surgery duration (extracted from patients’ medical records).Results:Patients receiving preoperative hypnosis reported significantly lower postoperative fatigue (mean difference [MD], 6.4; 95% CI, 0.40 to 12.4; Cohen’s d = 0.30) and emotional distress (MD, 5.7; 95% CI, 0.24 to 11.2; d = 0.24) when compared to patients in a mindfulness control group. There was also a significant reduction in postoperative fentanyl use among those patients receiving preoperative hypnosis (MD, −0.03; 95% CI, −0.047 to −0.005; d = 0.54). Preoperative anxiety moderated the effect of hypnosis on postoperative emotional distress, showing a more pronounced benefit for patients with high levels of preoperative anxiety. However, no significant differences were found in postoperative pain, nausea, or discomfort between the hypnosis and mindfulness groups. No adverse events attributed to the interventions were reported.Conclusions:A brief preoperative hypnosis session before breast cancer surgery appears to be more effective than mindfulness in reducing postoperative fatigue, emotional distress, and fentanyl dose. Hypnosis stands out as a promising, nonpharmacologic, and safe intervention for reducing certain postoperative symptoms.