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

NCT01746641 | Terminated Phase 4 DMC

• 1 other identifier: Acta No. 197
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Remifentanil; Propofol; Sedation; Endoscopy; Gastroenterology; Target controlled infusion effect site

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.

  At the end of the procedure, expected average of 30 minutes

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Level of consciousness

  Every minute until the end of the procedure, expected average of 30 minutes

Study Arms (2)

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.

Drug: Remifentanil

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.

Drug: Propofol

Interventions

Remifentanil DRUG

Remifentanil

Propofol DRUG

Propofol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Universitaria de Ciencias de la Salud: lead
• Hospital de San Jose: collaborator

Study Sites (1)

Fundación Universitaria de Ciencias de la Salud

Bogotá, Bogota D.C., 11001000, Colombia

Location

MeSH Terms

Conditions

Pain

Interventions

Remifentanil; Propofol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Luis A Muñoz, MD

  Fundacion Universitaria de Ciencias de la Salud

  STUDY DIRECTOR

• Luis E Reyes, MD

  Fundacion Universitaria de Ciencias de la Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: December 11, 2012
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

CO (1)