Dataset Information

Safety and efficacy of remifentanil-propofol combination on "muscle relaxant-free" general anesthesia for therapeutic endoscopic retrograde cholangiopancreatography: a randomized controlled trial.

ABSTRACT:

Objective

To prospectively evaluate the safety and efficacy of a "muscle relaxant-free" general anesthesia using a combination of remifentanil and propofol, compared to propofol-based monitored anesthesia care and conventional general anesthesia during therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Methods

From September to December 2019, 360 patients scheduled for elective ERCP at the Endoscopy Center of the First Affiliated Hospital of Nanjing Medical University were randomly assigned to three different groups: Group MAC (propofol-based monitored anesthesia care, n=120), Group GA₁ (general anesthesia with neuromuscular blocking agents, n=120), or Group GA₂ (remifentanil-propofol combination-based muscle relaxant-free general anesthesia, n=120).

Results

The results showed that there was a significant difference in intraprocedural cardiopulmonary adverse events among the three groups (Group MAC, 37.5%; Group GA₁, 19.2%; Group GA₂, 17.5%; P < 0.001). Total time (from patient entry into the Endoscopy Center to departure) and room time (from patient entry into the endoscopy suit to departure) were shorter in Group GA₂ and Group MAC compared to Group GA₁ (P < 0.001). Additionally, endoscopist satisfaction levels were significantly higher in Group GA₁ and Group GA₂ compared to Group MAC (P < 0.001).

Conclusion

The study found that administering propofol-remifentanil combination for "muscle relaxant-free" general anesthesia during therapeutic ERCP was safe and effective. This approach offered greater safety and endoscopist satisfaction than propofol-based monitored anesthesia care, as well as shorter total time and room time than conventional general anesthesia.

SUBMITTER: Wu J

PROVIDER: S-EPMC10492087 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Safety and efficacy of remifentanil-propofol combination on "muscle relaxant-free" general anesthesia for therapeutic endoscopic retrograde cholangiopancreatography: a randomized controlled trial.

Wu Junbei J Li Nana N Zhang Jigang J Tang Xiaoyang X Cao Xiaofei X

American journal of translational research 20230815 8

<h4>Objective</h4>To prospectively evaluate the safety and efficacy of a "muscle relaxant-free" general anesthesia using a combination of remifentanil and propofol, compared to propofol-based monitored anesthesia care and conventional general anesthesia during therapeutic endoscopic retrograde cholangiopancreatography (ERCP).<h4>Methods</h4>From September to December 2019, 360 patients scheduled for elective ERCP at the Endoscopy Center of the First Affiliated Hospital of Nanjing Medical Univers ...[more]

PMID: 37692944

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Project description: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.

Project description:BackgroundEndoscopic Retrograde Cholangiopancreatography (ERCP) is a complex endoscopic procedure that requires moderate to deep sedation. Propofol is the sedative agent of choice for sedation in ERCP due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Benzydamine hydrochloride is a topical non-steroidal anti-inflammatory drug that has analgesic, local anesthetic, and anti-inflammatory effects that have been known to be effective in reducing postoperative sore throat. Combination of propofol and topical analgesic may provide adequate sedation and reduce propofol consumption. This study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the ERCP procedure.MethodsThis study was a single-blind randomized controlled trial for patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018. A total of 72 subjects were recruited consecutively and randomly assigned into two groups. The first group received 15 mL of 0.15% benzydamine hydrochloride mouthwash prior to the procedure, whereas the second group received 15 mL of water mouthwash. Additional propofol was administered when patient moved or Ramsay Sedation Scale rose above 4. Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat were recorded in each group. Incidence of desaturation, postoperative nausea vomitting, and dysphagia were also recorded. Data analysis was performed with Statistical Package for the Social Sciences.ResultsCumulative propofol consumption per minute per kg body weight in the benzydamine hydrochloride group was 152.7 (91.9-238.8) mcg/kg/minute, while in the control group was 200.05 (114.4-380.2) mcg/kg/ minute (p = < 0.001). The incidence of sore throat on the 0th, 2nd, and 4th hour for the benzydamine hydrochloride group was 11.4, 11.4, and 5.7%, while in the control group was 50, 52.8, and 36.1% (p = < 0.001, < 0.001, 0.003). Desaturation was found in control group whereas none in benzydamine hydrochloride group. Complaints of nausea and vomiting were comparable in both groups.ConclusionBenzydamine hydrochloride gargling was effective in reducing cumulative propofol consumption in the ERCP procedure.Trial registrationStudy was registered retrospectively in ClinicalTrials.gov with NCT04167592 on November 8th 2019.

Dataset Information

Safety and efficacy of remifentanil-propofol combination on "muscle relaxant-free" general anesthesia for therapeutic endoscopic retrograde cholangiopancreatography: a randomized controlled trial.

Objective

Methods

Results

Conclusion

Publications

Safety and efficacy of remifentanil-propofol combination on "muscle relaxant-free" general anesthesia for therapeutic endoscopic retrograde cholangiopancreatography: a randomized controlled trial.

Similar Datasets

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