Clinical trial NCT04087668: Different Anesthetic Technique For ERCP
Official title: Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Adverse Effect
Keywords: ERCP
General anesthesia
Endoscopy
MAC
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: The overall complication rate
timeFrame: within 72 hours of ERCP
Secondary outcomes:
measure: Conversion to GA
timeFrame: During the procedure
measure: Temporary interruption rate of ERCP
timeFrame: During the procedure
measure: Premature termination rate of ERCP
timeFrame: During the procedure
measure: Procedural failure rate of ERCP
timeFrame: During the procedure
measure: Procedure time
timeFrame: During the procedure
measure: Anesthesia time
timeFrame: During the procedure
measure: Room time
timeFrame: During the procedure
measure: Immediate Adverse Events
timeFrame: within 24 hours of ERCP
measure: Delayed Adverse Events
timeFrame: within 72 hours of ERCP
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaofei Cao
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Junbei Wu
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Nana Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaoyang Tang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jigang Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith A, Silvestro L, Rodriguez RE, Austin PN. Evidence-Based Selection of Sedation Agents for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Gastroenterol Nurs. 2016 Jan-Feb;39(1):32-41. doi: 10.1097/SGA.0000000000000195.
citation: Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29.
citation: Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23.
citation: Coghlan SF, McDonald PF, Csepregi G. Use of alfentanil with propofol for nasotracheal intubation without neuromuscular block. Br J Anaesth. 1993 Jan;70(1):89-91. doi: 10.1093/bja/70.1.89.
citation: Grant S, Noble S, Woods A, Murdoch J, Davidson A. Assessment of intubating conditions in adults after induction with propofol and varying doses of remifentanil. Br J Anaesth. 1998 Oct;81(4):540-3. doi: 10.1093/bja/81.4.540.
citation: Erhan E, Ugur G, Gunusen I, Alper I, Ozyar B. Propofol - not thiopental or etomidate - with remifentanil provides adequate intubating conditions in the absence of neuromuscular blockade. Can J Anaesth. 2003 Feb;50(2):108-15. doi: 10.1007/BF03017840.
citation: Klemola UM, Mennander S, Saarnivaara L. Tracheal intubation without the use of muscle relaxants: remifentanil or alfentanil in combination with propofol. Acta Anaesthesiol Scand. 2000 Apr;44(4):465-9. doi: 10.1034/j.1399-6576.2000.440419.x.