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Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agostoni Massimo, Fondazione SanRaffaele del Monte Tabor
ClinicalTrials.gov Identifier:
NCT01229527
First received: October 26, 2010
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Colonoscopy
 Drug: Remifentanil
Drug: Meperidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Ospedale San Raffaele:

Primary Outcome Measures:
  • Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 [ Time Frame: > 0 minutes ] [ Designated as safety issue: No ]
    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:
  • Patient's Satisfaction [ Time Frame: After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remifentanil RS1 Drug: Remifentanil
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 Drug: Remifentanil
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 Drug: Meperidine
Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229527

Locations
Italy
San Raffaele Hospital
Milan, Italy, 20132
Sponsors and Collaborators
Ospedale San Raffaele
  More Information

No publications provided

Responsible Party: Agostoni Massimo, Medical Doctor, Fondazione SanRaffaele del Monte Tabor
ClinicalTrials.gov Identifier: NCT01229527     History of Changes
Other Study ID Numbers: PCSA/Remi 2009
Study First Received: October 26, 2010
Results First Received: September 19, 2011
Last Updated: January 2, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Ospedale San Raffaele:
Colonoscopy
Remifentanil
Sedation

Additional relevant MeSH terms:
Meperidine
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013