Comparison Between Two Different Dosages of Remifentanil Administered by PCSA (Patient Controlled Sedation and Analgesia) and Meperidine During Colonoscopy: A Randomized Double-Blind Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Discharge Time, the Time to Reach a Modified Aldrete Score ≥18
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult Patients
- •Diagnostic and Operative Colonoscopy
- •ASA Physical Status I-II
Exclusion Criteria
- •Age < 18 years
Arms & Interventions
Remifentanil RS1
Intervention: Remifentanil (Drug)
Remifentanil RS2
Intervention: Remifentanil (Drug)
Meperidine
Intervention: Meperidine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Patient's Satisfaction(After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone)
Investigators
Agostoni Massimo
Medical Doctor
Ospedale San Raffaele