Phase 4
Completed N=140
Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.
Disorders of Gallbladder, Biliary Tract and Pancrease
Source: ClinicalTrials.gov NCT01709422 ↗
Enrolled (actual)
140
Serious AEs
0.7%
Results posted
Aug 2013
Primary outcomePrimary: Procedure Related Time — 40.67; 43.24; 3.94; 5.47 minutes — p=0.05
Summary
The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Related Time |
40.67; 43.24; 3.94; 5.47; 24.71; 88.50 | 0.05 |
| SECONDARY Cardiovascular Adverse Events. |
26; 40; 12; 14; 1; 0 | 0.05 |
Eligibility Criteria
Inclusion Criteria
. All outpatients aged more than 18 years who were schedule for ERCP -
Exclusion Criteria
- pregnant woman
- emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute cholangitis )
- American Society of Anesthesiologist ( ASA )Class IV or V
- respiratory disease,
- sleep apnea
- allergy to egg or soybean
- drug abuse( benzodiazepine, opioid agonist )
- previous history of failure sedation
Data sourced from ClinicalTrials.gov (NCT01709422). 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.