Sedation of Advanced Endoscopic Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-08-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

advanced endoscopic procedure

Intervention Type PROCEDURE

The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.

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)

Group Type ACTIVE_COMPARATOR

advanced endoscopic procedure

Intervention Type PROCEDURE

The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.

Interventions

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advanced endoscopic procedure

The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No