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Completed

NCT Number: NCT04087668

Different Anesthetic Technique For ERCP

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.

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Key information

Conditions

Anesthesia; Adverse Effect

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitored anesthesia care

Procedure

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 Anesthesia

Procedure

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 Blockade

Procedure

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 .

Primary outcomes

  1. The overall complication rate

    Time frame: within 72 hours of ERCP

    The primary outcome was the overall pulmonary and cardiac complication rate.

Secondary outcomes

  1. Conversion to GA

    Time frame: During the procedure

    Conversion to general anesthesia

  2. Temporary interruption rate of ERCP

    Time frame: During the procedure

  3. Premature termination rate of ERCP

    Time frame: During the procedure

  4. Procedural failure rate of ERCP

    Time frame: During the procedure

  5. Procedure time

    Time frame: During the procedure

  6. Anesthesia time

    Time frame: During the procedure

  7. Room time

    Time frame: During the procedure

    Patient room-in to room-out time in the ERCP suite ("room time").

  8. Immediate Adverse Events

    Time frame: within 24 hours of ERCP

  9. Delayed Adverse Events

    Time frame: within 72 hours of ERCP

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2019
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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