Comparison Between Two Different Dosages of Remifentanil During Colonoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01229527|
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : February 1, 2012
Last Update Posted : February 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: Remifentanil Drug: Meperidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison Between Two Different Dosages of Remifentanil Administered by PCSA (Patient Controlled Sedation and Analgesia) and Meperidine During Colonoscopy: A Randomized Double-Blind Trial|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|Experimental: Remifentanil RS1||
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.
|Experimental: Remifentanil RS2||
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.
|Active Comparator: Meperidine||
Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.
- Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 [ Time Frame: > 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.
- Patient's Satisfaction [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229527
|San Raffaele Hospital|
|Milan, Italy, 20132|