Different Anesthetic Technique For ERCP

Overview

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.

Full Title of Study: “Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2019

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.

Interventions

  • 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.
  • 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 .
  • 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 .

Arms, Groups and Cohorts

  • Other: Monitored Anesthesia Care
    • Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation.
  • Other: General Anesthesia
    • Patients in this arm will receive standard general anesthesia with neuromuscular blockade.
  • Other: General Anesthesia Without Neuromuscular Blockade
    • Patients in this arm will receive nasotracheal intubation without neuromuscular blockade.

Clinical Trial Outcome Measures

Primary Measures

  • The overall complication rate
    • Time Frame: within 72 hours of ERCP
    • The primary outcome was the overall pulmonary and cardiac complication rate.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital with Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiaofei Cao, Study Chair, The First Affiliated Hospital with Nanjing Medical University
    • Junbei Wu, Study Director, The First Affiliated Hospital with Nanjing Medical University
    • Nana Li, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
    • Xiaoyang Tang, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
    • Jigang Zhang, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University

References

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.