Trial | NCT01746641  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Indication/Condition

    Pain

  • Study Participants

    69
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.
Study Started
Jan 31
2010
Primary Completion
Jun 30
2010
Study Completion
Jun 30
2010
Last Update
Dec 11
2012
Estimate

Drug Remifentanil

Drug Propofol

Remifentanil Active Comparator

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.

Propofol Active Comparator

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.

Criteria 

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.
No Results Posted