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Phase 4 Completed N=90 Randomized Double-blind Supportive Care

Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

Colonoscopy
Source: ClinicalTrials.gov NCT01229527 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 — 0; 0; 2 minutes

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.

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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