Different Anesthetic Technique For ERCP
- Conditions
- Anesthesia; Adverse Effect
- Interventions
- Procedure: General AnesthesiaProcedure: Monitored Anesthesia CareProcedure: Induction Without Neuromuscular Blockade
- Registration Number
- NCT04087668
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description General Anesthesia General Anesthesia Patients in this arm will receive standard general anesthesia with neuromuscular blockade. Monitored Anesthesia Care Monitored Anesthesia Care Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation. General Anesthesia Without Neuromuscular Blockade Induction Without Neuromuscular Blockade Patients in this arm will receive nasotracheal intubation without neuromuscular blockade.
- Primary Outcome Measures
Name Time Method The overall complication rate within 72 hours of ERCP The primary outcome was the overall pulmonary and cardiac complication rate.
- Secondary Outcome Measures
Name Time Method Anesthesia time During the procedure Premature termination rate of ERCP During the procedure Procedural failure rate of ERCP During the procedure Conversion to GA During the procedure Conversion to general anesthesia
Temporary interruption rate of ERCP During the procedure Procedure time During the procedure Delayed Adverse Events within 72 hours of ERCP Room time During the procedure Patient room-in to room-out time in the ERCP suite ("room time").
Immediate Adverse Events within 24 hours of ERCP
Trial Locations
- Locations (1)
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China