Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Remifentanil
* Drug: Meperidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients Diagnostic and Operative Colonoscopy ASA Physical Status I-II Exclusion Criteria: Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil RS1<br> | Drug: Remifentanil<br>* 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.<br>|
| Experimental: Remifentanil RS2<br> | Drug: Remifentanil<br>* 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.<br>|
| Active Comparator: Meperidine<br> | Drug: Meperidine<br>* Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | 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. | > 0 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Satisfaction | 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. | After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Remifentanil, Sedation