Sedation of Advanced Endoscopic Procedure

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

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.

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

Conditions
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Sedation

Intervention / Treatment
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* Procedure: advanced endoscopic procedure


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced endoscopic procedure, ERCP, EUS, target-controlled infusion, sedation, propofol