Different Anesthetic Technique For ERCP

Nanjing Medical University

Status: Completed

Conditions: Anesthesia; Adverse Effect

Treatments: Procedure: Induction Without Neuromuscular Blockade; Procedure: Monitored Anesthesia Care; Procedure: General Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04087668

2019-SR-205

Details and patient eligibility

About

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 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.

Enrollment: 405 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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405 participants in 3 patient groups

Monitored Anesthesia Care

Other group

Description:

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

Treatment:

Procedure: Monitored Anesthesia Care

General Anesthesia

Other group

Description:

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

Treatment:

Procedure: General Anesthesia

General Anesthesia Without Neuromuscular Blockade

Other group

Description:

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

Treatment:

Procedure: Induction Without Neuromuscular Blockade