Different Anesthetic Technique For ERCP

Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

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 Overview

• Status: Completed
• Conditions: Anesthesia; Adverse Effect
• Intervention / Treatment: Procedure: Monitored Anesthesia Care; Procedure: General Anesthesia; Procedure: Induction Without Neuromuscular Blockade

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 Type: Interventional
• Enrollment (Actual): 405
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Monitored Anesthesia Care; Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation.	Procedure: Monitored Anesthesia Care; 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.
Other: General Anesthesia; Patients in this arm will receive standard general anesthesia with neuromuscular blockade.	Procedure: General Anesthesia; 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 .
Other: General Anesthesia Without Neuromuscular Blockade; Patients in this arm will receive nasotracheal intubation without neuromuscular blockade.	Procedure: Induction Without Neuromuscular Blockade; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall complication rate	The primary outcome was the overall pulmonary and cardiac complication rate.	within 72 hours of ERCP

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Xiaofei Cao, The First Affiliated Hospital with Nanjing Medical University; Study Director: Junbei Wu, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Nana Li, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Xiaoyang Tang, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Jigang Zhang, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

General Publications

• Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29. Erratum In: Dig Dis Sci. 2016 Jul;61(7):2146.
• Smith A, Silvestro L, Rodriguez RE, Austin PN. Evidence-Based Selection of Sedation Agents for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Gastroenterol Nurs. 2016 Jan-Feb;39(1):32-41. doi: 10.1097/SGA.0000000000000195.
• Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23.
• Coghlan SF, McDonald PF, Csepregi G. Use of alfentanil with propofol for nasotracheal intubation without neuromuscular block. Br J Anaesth. 1993 Jan;70(1):89-91. doi: 10.1093/bja/70.1.89.
• Grant S, Noble S, Woods A, Murdoch J, Davidson A. Assessment of intubating conditions in adults after induction with propofol and varying doses of remifentanil. Br J Anaesth. 1998 Oct;81(4):540-3. doi: 10.1093/bja/81.4.540.
• Erhan E, Ugur G, Gunusen I, Alper I, Ozyar B. Propofol - not thiopental or etomidate - with remifentanil provides adequate intubating conditions in the absence of neuromuscular blockade. Can J Anaesth. 2003 Feb;50(2):108-15. doi: 10.1007/BF03017840.
• Klemola UM, Mennander S, Saarnivaara L. Tracheal intubation without the use of muscle relaxants: remifentanil or alfentanil in combination with propofol. Acta Anaesthesiol Scand. 2000 Apr;44(4):465-9. doi: 10.1034/j.1399-6576.2000.440419.x.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Endoscopy; ERCP; MAC; General anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2019-SR-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No