Different Anesthetic Technique For ERCP

Study Overview
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Brief Summary
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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
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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.

Official Title
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Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography

Conditions
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Anesthesia; Adverse Effect

Intervention / Treatment
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* Procedure: Monitored Anesthesia Care
* Procedure: General Anesthesia
* Procedure: Induction Without Neuromuscular Blockade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Monitored Anesthesia Care<br>Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation. | Procedure: Monitored Anesthesia Care<br>* 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.<br>|
| Other: General Anesthesia<br>Patients in this arm will receive standard general anesthesia with neuromuscular blockade. | Procedure: General Anesthesia<br>* 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 .<br>|
| Other: General Anesthesia Without Neuromuscular Blockade<br>Patients in this arm will receive nasotracheal intubation without neuromuscular blockade. | Procedure: Induction Without Neuromuscular Blockade<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall complication rate | The primary outcome was the overall pulmonary and cardiac complication rate. | within 72 hours of ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to GA | Conversion to general anesthesia | 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 | 
| Anesthesia time |  | During the procedure | 
| Room time | Patient room-in to room-out time in the ERCP suite (room time). | During the procedure | 
| Immediate Adverse Events |  | within 24 hours of ERCP | 
| Delayed Adverse Events |  | within 72 hours of ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, General anesthesia, Endoscopy, MAC