Different Anesthetic Technique For ERCP

Anesthesia; Adverse Effect Clinical Trial

Official title:

Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087668
• Other study ID #: 2019-SR-205
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18-70 years old

• Grade ? and ? 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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect

Intervention

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.
• 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 .
• 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 .

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall complication rate	The primary outcome was the overall pulmonary and cardiac complication rate.	within 72 hours of ERCP
Secondary	Conversion to GA	Conversion to general anesthesia	During the procedure
Secondary	Temporary interruption rate of ERCP		During the procedure
Secondary	Premature termination rate of ERCP		During the procedure
Secondary	Procedural failure rate of ERCP		During the procedure
Secondary	Procedure time		During the procedure
Secondary	Anesthesia time		During the procedure
Secondary	Room time	Patient room-in to room-out time in the ERCP suite ("room time").	During the procedure
Secondary	Immediate Adverse Events		within 24 hours of ERCP
Secondary	Delayed Adverse Events		within 72 hours of ERCP