Anesthesia; Adverse Effect
Conditions
Keywords
ERCP, General anesthesia, Endoscopy, MAC
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.
Interventions
PROCEDUREMonitored 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.
PROCEDUREGeneral 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 .
PROCEDUREInduction 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 .
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall complication rate | within 72 hours of ERCP | The primary outcome was the overall pulmonary and cardiac complication rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Premature termination rate of ERCP | During the procedure | — |
| 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 | — |
| Delayed Adverse Events | within 72 hours of ERCP | — |
| Anesthesia time | During the procedure | — |
Countries
China
Outcome results
None listed