Phase 4
Completed N=60
Remifentanil Only vs. Midazolam and Meperidine During Elective Colonoscopy
Diagnostic Colonoscopy Screening
Source: ClinicalTrials.gov NCT01693185 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: The Recovery Time — 0; 30 minute — p=< 0.001
Summary
The aim of the present study is to compare patient's recovery times after elective colonoscopy employing remifentanil only vs conventional combination of midazolam and meperidine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Recovery Time |
0; 30 | < 0.001 sig |
| SECONDARY Participants Assumed to Feel Frequent Pain |
4; 7 | — |
| SECONDARY Bispectra Lindex Score |
92; 84 | — |
| SECONDARY Patient's Distress Score |
37; 30 | — |
| SECONDARY Endoscopist Satisfaction |
5; 20 | — |
| SECONDARY Indigence of Patient's Recall |
27; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 19-65 years
- American Society of Anesthesiologists physical status (ASA PS) 1-2
- Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital
- Patients who signed on written informed consent.
Exclusion Criteria
- The exclusion criteria are refusal or inability to provide written informed consent
- Age < 18 years
- Pregnancy
- Previous large bowel surgery
- Psychiatric disorders
- History of addiction to opiates and / or sedatives, and previous adverse reaction to any drug used in the study.
Data sourced from ClinicalTrials.gov (NCT01693185). 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.