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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
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Anesthesia; Adverse Effect Procedure: Monitored Anesthesia Care Procedure: General Anesthesia Procedure: Induction Without Neuromuscular Blockade Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Arm Intervention/treatment
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.

General Anesthesia
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 .




Primary Outcome Measures :
  1. The overall complication rate [ Time Frame: within 72 hours of ERCP ]
    The primary outcome was the overall pulmonary and cardiac complication rate.


Secondary Outcome Measures :
  1. Conversion to GA [ Time Frame: During the procedure ]
    Conversion to general anesthesia

  2. Temporary interruption rate of ERCP [ Time Frame: During the procedure ]
  3. Premature termination rate of ERCP [ Time Frame: During the procedure ]
  4. Procedural failure rate of ERCP [ Time Frame: During the procedure ]
  5. Procedure time [ Time Frame: During the procedure ]
  6. Anesthesia time [ Time Frame: During the procedure ]
  7. Room time [ Time Frame: During the procedure ]
    Patient room-in to room-out time in the ERCP suite ("room time").

  8. Immediate Adverse Events [ Time Frame: within 24 hours of ERCP ]
  9. Delayed Adverse Events [ Time Frame: within 72 hours of ERCP ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaofei Cao +86 13584002389 xiaofei_cao@sina.com
Contact: Junbei Wu +86 13813955365 wujunbei88@sina.cn

Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact    008625-83714511      
Contact    008625-83718836      
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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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

Publications:

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04087668     History of Changes
Other Study ID Numbers: 2019-SR-205
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
ERCP
General anesthesia
Endoscopy
MAC
Additional relevant MeSH terms:
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Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General