Phase 4 N=90 Randomized Double-blind Supportive Care

Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Colonoscopy

Bottom Line

View on ClinicalTrials.gov: NCT01229527 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2012

Primary outcome: Primary: Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 — 0; 0; 2 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Remifentanil (Drug); Meperidine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ospedale San Raffaele
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Discharge Time, the Time to Reach a Modified Aldrete Score ≥18	0; 0; 2	—
SECONDARY Patient's Satisfaction	95.87; 93.50; 96.27	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Age < 18 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01229527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.