Different Anesthetic Technique For ERCP

NCT04087668 | Completed DMC

• 1 other identifier: 2019-SR-205
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Adverse Effect

Keywords

ERCP; General anesthesia; Endoscopy; MAC

Outcome Measures

Primary Outcomes (1)

• The overall complication rate

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

  within 72 hours of ERCP

Secondary Outcomes (9)

• Conversion to GA

  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

Study Arms (3)

Monitored Anesthesia Care

OTHER

Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation.

Procedure: Monitored Anesthesia Care

General Anesthesia

OTHER

Patients in this arm will receive standard general anesthesia with neuromuscular blockade.

Procedure: General Anesthesia

General Anesthesia Without Neuromuscular Blockade

OTHER

Patients in this arm will receive nasotracheal intubation without neuromuscular blockade.

Procedure: Induction Without Neuromuscular Blockade

Interventions

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.

Monitored Anesthesia Care

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 .

General Anesthesia

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 .

General Anesthesia Without Neuromuscular Blockade

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (7)

• 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.

  PMID: 26825562 BACKGROUND

• 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.

  PMID: 26825844 BACKGROUND

• 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.

  PMID: 23877477 BACKGROUND

• 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.

  PMID: 8431342 BACKGROUND

• 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.

  PMID: 9924229 BACKGROUND

• 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.

  PMID: 12560298 BACKGROUND

• 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.

  PMID: 10757583 BACKGROUND

MeSH Terms

Interventions

Anesthesia, General; Neoadjuvant Therapy; Neuromuscular Blockade

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Combined Modality Therapy; Therapeutics; Investigative Techniques

Study Officials

• Xiaofei Cao

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• Junbei Wu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: September 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)