NCT01229527

Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Comparison Between Two Different Dosages of Remifentanil Administered by PCSA (Patient Controlled Sedation and Analgesia) and Meperidine During Colonoscopy: A Randomized Double-Blind Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects. 90 patients undergoing colonoscopy will be enrolled.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	Remifentanil	Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button.
DRUG	Remifentanil	Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button.
DRUG	Meperidine	Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-10-27
• Last updated: 2012-02-01
• Results posted: 2012-02-01

Locations

1 site across 1 country: Italy