CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 405 enrolled
Drug / intervention
Monitored Anesthesia Care +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04087668
NCT04087668N/ACompleted

Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

The First Affiliated Hospital with Nanjing Medical University·interventional·Posted Sep 12, 2019·Updated May 24, 2023

In Brief

A clinical study evaluating Monitored Anesthesia Care, General Anesthesia, and 1 other intervention for Anesthesia; Adverse Effect. Completed, enrolled 405 participants across 1 site.

Detailed Summary

Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general anesthesia and general anesthesia without neuromuscular blockade in patients undergoing ERCP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 12, 2019
Enrollment StartSep 1, 2019
Primary CompletionDec 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.8 years ago

Interventions

Monitored Anesthesia Careprocedure

MAC was induced and maintained via the continuous infusion of propofol AND remifentanil using a target-controlled infusion (TCI) pump. The appropriate level of sedation was 65 to 80 points on BIS. The adjunctive sedatives (eg, fentanyl, midazolam) was at the discretion of the anesthesia team.

General Anesthesiaprocedure

Induction was done with propofol (2 mg/kg) , cis-atracurium (0.15 mg/kg) , and fentanyl (5μg/kg). After orotracheal intubation, general anesthesia was maintained with sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min) and repetitive doses of 0.1mg atracurium per kilogram were administered. After the procedure was completed, neostigmine mixed with atropine was used as a reversal agent for the neuromuscular blockade, and the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .

Induction Without Neuromuscular Blockadeprocedure

Anaesthesia was induced with propofol (2 mg/kg), remifentanil(3 ug/kg) and 2% lidocaine (1 mg/kg). Nasotracheal intubation was performed 60 s after the administration. After intubation, general anesthesia was sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min). After the procedure was completed, the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .