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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01746641
• Other study ID #: Acta No. 197
• Status: Terminated
• Phase: Phase 4
• First received: July 30, 2012
• Last updated: December 8, 2012
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: December 2012
• Source: Fundación Universitaria de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosColombia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Remifentanil

• Propofol

Locations

Country	Name	City	State
Colombia	Fundación Universitaria de Ciencias de la Salud	Bogota

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Universitaria de Ciencias de la Salud	Hospital de San Jose

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of consciousness	Ramsay scale.	Every minute until the end of the procedure, expected average of 30 minutes	No
Primary	Patient satisfaction	Measured with a analog scale from 1 to 4: Excellent.; Good.; Regular.; No.	At the end of the procedure, expected average of 30 minutes	No
Secondary	Gastroenterologist satisfaction	Measured with a analog scale from 1 to 4: Excellent.; Good.; Regular.; No.	At the end of the procedure, expected average of 30 minutes	No
Secondary	Adverse events	Occurrence of cardiac arrythmias, mild respiratory depression, severe respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, absence of amnesia.	At the end of the procedure, expected average of 30 minutes	Yes