Different Anesthetic Technique For ERCP
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|ClinicalTrials.gov Identifier: NCT04087668|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia; Adverse Effect||Procedure: Monitored Anesthesia Care Procedure: General Anesthesia Procedure: Induction Without Neuromuscular Blockade||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Monitored Anesthesia Care
Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation.
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.
Patients in this arm will receive standard general anesthesia with neuromuscular blockade.
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 .
General Anesthesia Without Neuromuscular Blockade
Patients in this arm will receive nasotracheal intubation without neuromuscular blockade.
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 .
- The overall complication rate [ Time Frame: within 72 hours of ERCP ]The primary outcome was the overall pulmonary and cardiac complication rate.
- Conversion to GA [ Time Frame: During the procedure ]Conversion to general anesthesia
- Temporary interruption rate of ERCP [ Time Frame: During the procedure ]
- Premature termination rate of ERCP [ Time Frame: During the procedure ]
- Procedural failure rate of ERCP [ Time Frame: During the procedure ]
- Procedure time [ Time Frame: During the procedure ]
- Anesthesia time [ Time Frame: During the procedure ]
- Room time [ Time Frame: During the procedure ]Patient room-in to room-out time in the ERCP suite ("room time").
- Immediate Adverse Events [ Time Frame: within 24 hours of ERCP ]
- Delayed Adverse Events [ Time Frame: within 72 hours of ERCP ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087668
|Contact: Xiaofei Cao||+86 email@example.com|
|Contact: Junbei Wu||+86 firstname.lastname@example.org|
|The First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Study Chair:||Xiaofei Cao||The First Affiliated Hospital with Nanjing Medical University|
|Study Director:||Junbei Wu||The First Affiliated Hospital with Nanjing Medical University|
|Principal Investigator:||Yin Fang||The First Affiliated Hospital with Nanjing Medical University|
|Principal Investigator:||Tao Qi||The First Affiliated Hospital with Nanjing Medical University|
|Principal Investigator:||Jing Chen||The First Affiliated Hospital with Nanjing Medical University|