Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Remifentanil; Drug: Meperidine

• Registration Number: NCT01229527
• Lead Sponsor: Ospedale San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-09-19
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-02
• Last Update Submitted: 2012-01-02
• Results First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adult Patients
• Diagnostic and Operative Colonoscopy
• ASA Physical Status I-II

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil RS1	Remifentanil	-
Remifentanil RS2	Remifentanil	-
Meperidine	Meperidine	-

Primary Outcome Measures

Name	Time	Method
Discharge Time, the Time to Reach a Modified Aldrete Score ≥18	> 0 minutes	Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.

Secondary Outcome Measures

Name	Time	Method
Patient's Satisfaction	After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone	The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy