Sedation of Advanced Endoscopic Procedure

Effects of Target-controlled Infusion and Bispectral Index Monitoring in Sedation of Advanced Endoscopic Procedure

To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure.

Study Overview

• Status: Completed
• Conditions: Sedation
• Intervention / Treatment: Procedure: advanced endoscopic procedure

Detailed Description

Anesthesia requirements for advanced endoscopic procedures are approaching those of specialized surgical interventions. Although many other sedative agents are used prior to and during endoscopy, none approach propofol in terms of desirable properties. The risk of propofol sedation for interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), and therapeutic endoscopy are among the highest for any sedated endoscopic procedure. The reasons are many: the intensity of stimulation encountered during these procedures is similar to many minor surgeries; the airway management is complex and requires constant attention; the incidence of hypoxemia is high, and the time available for recognition and management is limited. In order to reap the benefits of advanced endoscopic procedures, anesthesiologists must rise to the challenge. This requires a dedicated anesthetic team practicing safe, efficient, and effective sedation techniques for advanced endoscopic procedures. Ongoing research into novel infusion methods can add safety to the existing sedation techniques and address some of the concerns related to sedative quality. This is a randomized controlled and prospective study. To evaluate the benefits when we use target-controlled infusion of propofol (TCI) with/without bispectral index monitoring in patients undergoing advanced endoscopic procedure. The primary outcome is the total amount of propofol. The secondary outcomes are patients' and endoscopists' satisfaction, sedative-related adverse events, recovery time.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergo advanced endoscopic procedure

Exclusion Criteria:

• age less than 20 years, pregnant and lactating women, American Society of Anesthesiologists (ASA) class V, allergy to propofol, benzodiazepine, or opioid, and a requirement for general anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Target-control infusion without bispectral index monitoring; Target-control infusion (TCI) with propofol during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP)	Procedure: advanced endoscopic procedure; The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.
Active Comparator: Target-control infusion with bispectral index monitoring; Target-control infusion (TCI) with propofol and BIS monitoring during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP)	Procedure: advanced endoscopic procedure; The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
propofol dose	Total amount of propofol during the procedure	during the endoscopic procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation-related adverse events	hypotension, hypoxemia	during the endoscopic procedure
Quality of sedation	The satisfaction of the endoscopist with the sedation is evaluated by a case-by-case questionnaire. Four classes of response: excellent, good, acceptable and poor, were defined for the overall evaluation with the safety of endoscopy procedure, patient cooperation and fluency of the procedure in the opinion of the endoscopist. Patients' satisfaction includes their immediate evaluation of side effects such as post procedure dizziness, nausea/vomiting, or pain recall evaluation in the recovery room. Telephone interviews are performed to ascertain the patients' overall satisfaction evaluation and of the procedure with four classes of responses: excellent, good, acceptable and poor.	2 days
Recovery: open eye, conscious clear, discharge time	Recovery data include time from end of endoscopy until eye opening on command and time from end of endoscopy until leaving the recovery room based on Aldrete score ≧ 9.	within 2 hrs

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: LIN, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: ERCP; sedation; propofol; EUS; target-controlled infusion; advanced endoscopic procedure
• Other Study ID Numbers: 201612218RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No