Comparison Between Two Different Dosages of Remifentanil During Colonoscopy
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
October 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
February 1, 2012
CompletedFebruary 1, 2012
January 1, 2012
1.7 years
October 26, 2010
September 19, 2011
January 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Patient's Satisfaction
After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone
Study Arms (3)
Remifentanil RS1
EXPERIMENTALRemifentanil RS2
EXPERIMENTALMeperidine
ACTIVE COMPARATORInterventions
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.
Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.
Eligibility Criteria
You may qualify if:
- Adult Patients
- Diagnostic and Operative Colonoscopy
- ASA Physical Status I-II
You may not qualify if:
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Raffaele Hospital
Milan, 20132, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Massimo Agostoni
- Organization
- Department of Anesthesia and Intensive Care
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
October 26, 2010
First Posted
October 27, 2010
Study Start
April 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 1, 2012
Results First Posted
February 1, 2012
Record last verified: 2012-01