Different Anesthetic Technique For ERCP

Not Applicable

Completed

• Conditions: Anesthesia; Adverse Effect

• Registration Number: NCT04087668
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

ERCP is identified as one of the most invasive endoscopic procedures, during which patients may experience anxiety, discomfort and suffer different degree of pain. So, anesthesia and analgesia are essential for this invasive procedure, especially therapeutic ERCPs. Thus, we compared the efficacy of using monitored anesthesia care (MAC) with deep sedation versus general anesthesia (GA) to perform this procedure and the incidence of complications associated with these methods of anesthesia.

Previous studies have concluded that intubation is possible without the use of neuromuscular blockade. We assume that the use of propofol and adjuvants short-acting opioids may provide adequate conditions for tracheal intubation. It was also hypothesized that it may also be useful in facilitating ERCP under general anesthesia without neuromuscular blockade.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• Aged 18-70 years old
• Grade Ⅰ and Ⅲ according to physical status classification system of the American Society of Anesthesiologists (ASA)
• Coagulation function tests in normal range

Exclusion Criteria

• Potentially difficult airways
• Administration of sedative or narcotic drugs in the previous 24 hours
• Severe renal or hepatic impairment
• Severe cardiopulmonary comorbidities (defined as American Society of Anesthesiologists physical status IV or greater)
• Contraindications to a nasotracheal intubation
• Coagulopathy
• History of frequent episodes of epistaxis
• Emergent ERCP
• At risk for reflux and aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The overall complication rate	within 72 hours of ERCP	The primary outcome was the overall pulmonary and cardiac complication rate.

Secondary Outcome Measures

Name	Time	Method
Anesthesia time	During the procedure
Premature termination rate of ERCP	During the procedure
Procedural failure rate of ERCP	During the procedure
Conversion to GA	During the procedure	Conversion to general anesthesia
Temporary interruption rate of ERCP	During the procedure
Procedure time	During the procedure
Delayed Adverse Events	within 72 hours of ERCP
Room time	During the procedure	Patient room-in to room-out time in the ERCP suite ("room time").
Immediate Adverse Events	within 24 hours of ERCP

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China