Remifentanil sedation for outpatient endoscopic procedures

• Conditions: We are investigating the use of remifentanil for sedation in outpatient endoscopic procedures. It will be compared to 'current practice' sedation with midazolam and fentanyl. Patient who are due to undergo an outpatient endoscopic procedure as part of their clinical care will be recruited to the trial. Treatment with remifentanil will not last beyond their daycase admission.

• Registration Number: EUCTR2008-002106-19-GB
• Lead Sponsor: Chelsea & Westminster NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-16
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Participants will be recruited from patients scheduled for routine outpatient upper GI endoscopic procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General:
1) Patients with acute respiratory depression (unlikely for outpatient endoscopy patients)
2) Patients diagnosed with phaeochromocytoma (risk of pressor response to histamine release)
3) Patients with opiate or benzodiazepine dependence

Specific exclusion criteria for outpatient endoscopy patients:
1) Cardio-respiratory disease resulting in low oxygen saturations
2) Severe ventricular arrhythmias, heart failure or any other condition that may preclude endoscopy being done as an outpatient procedure
3) Patients taking antidepressant, benzodiazepine or any other psychotropic medication
4) Patients who are pregnant or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess in patients undergoing outpatient endoscopic procedures of the upper gastrointestinal (GI) tract, whether sedation with remifentanil and low-dose midazolam provides faster patient recovery time than with midazolam +/- fentanyl? This will be assessed using the Aldrete score, a validated scoring system for patient recovery time.<br>;Secondary Objective: 1.operator satisfaction with procedural performance<br>2.quality of diagnostic procedure: mucosal visualisation in diagnostic gastroscopy and image quality of endoscopic ultrasound<br>3.patient satisfaction with endoscopic procedure, using the Iowa satisfaction with anaesthesia scale (ISAS);Primary end point(s): Faster patient recovery time.<br><br>The study will not last beyond each patient's daycase admission.