A Phase 4 interventional study of Remifentanil and Propofol in Pain, sponsored by Fundación Universitaria de Ciencias de la Salud. Terminated at 1 site in Colombia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-12-11.
Sponsored by Fundación Universitaria de Ciencias de la Salud · Phase 4, Interventional, and Supportive care
The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.
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.
Fundación Universitaria de Ciencias de la Salud is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Patient satisfaction
Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.
Time frame: At the end of the procedure, expected average of 30 minutes
Gastroenterologist satisfaction
Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.
Time frame: 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.
Time frame: At the end of the procedure, expected average of 30 minutes
Level of consciousness
Ramsay scale.
Time frame: Every minute until the end of the procedure, expected average of 30 minutes
This study is terminated, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Fundación Universitaria de Ciencias de la Salud