NCT04087668

Different Anesthetic Technique For ERCP

Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthesia; Adverse Effect

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2019-09-12
• Last updated: 2023-05-24

Locations

1 site across 1 country: China