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

Fundación Universitaria de Ciencias de la Salud

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Drug: Propofol; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01746641

Acta No. 197

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Remifentanil

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil

Propofol

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol