Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures

Study Overview
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Brief Summary
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The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.

Detailed Description
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The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known. Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.

Official Title
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Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December 2010. Be between 18 and 70 years old. American Society of Anesthesiology Physical Status classification between 1 and 3. Provide written informed consent. Exclusion Criteria: Patients with difficult airway indicators. Pregnant women. Patients with chronic pain. Chronic opioid or benzodiazepine users (>3 months). Allergy history to remifentanil or propofol or eggs. Psychoactive drug users. Smokers (> 5 cigarettes per day in the previous 3 months). Body mass index > 30.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil<br>Remifentanil target controlled infusion effect site with Minto's pharmacokinetic model. Start dose: 1 ng/mL. Titration: 0.5 ng/mL according to clinical criteria. | Drug: Remifentanil<br> <br> |
| Active Comparator: Propofol<br>Propofol target controlled infusion effect site with Marsh's pharmacokinetic model. Start dose: 1 mcg/mL. Titration: 0.5 mcg/mL according to clinical criteria. | Drug: Propofol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Measured with a analog scale from 1 to 4: Excellent. Good. Regular. No. | At the end of the procedure, expected average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroenterologist satisfaction | Measured with a analog scale from 1 to 4: Excellent. Good. Regular. No. | At the end of the procedure, expected average of 30 minutes | 
| Adverse events | Occurrence of cardiac arrythmias, mild respiratory depression, severe respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, absence of amnesia. | At the end of the procedure, expected average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remifentanil, Propofol, Sedation, Endoscopy, Gastroenterology, Target controlled infusion effect site