drugset / Trial / NCT02436980

Premedication for ERCP With Midazolam or Tramadol

NCT02436980

Phase 4 Completed 40 enrolled Karadeniz Technical University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde cholangiopancreatography) METHODS:This randomized and double blind study was performed with forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned. Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who were randomly divided into two premedication groups. Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was considered as cognitive impairment. Recovery period, post-procedure state of cognitive function at 60th minute were recorded.

Timeline

Start
2009-01
Primary completion
2009-09
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.15 mg/kg Oral
Comparator Tramadol Other / unclassified 1 mg/kg Oral

Indications

No indication recorded.