Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Remifentanil
- Conditions
- Pain
- Sponsor
- Fundación Universitaria de Ciencias de la Salud
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December
- •Be between 18 and 70 years old.
- •American Society of Anesthesiology Physical Status classification between 1 and
- •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.
Arms & Interventions
Remifentanil
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.
Intervention: Remifentanil
Propofol
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.
Intervention: Propofol
Outcomes
Primary Outcomes
Patient satisfaction
Time Frame: At the end of the procedure, expected average of 30 minutes
Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.
Secondary Outcomes
- Gastroenterologist satisfaction(At the end of the procedure, expected average of 30 minutes)
- Adverse events(At the end of the procedure, expected average of 30 minutes)