Premedication for ERCP With Midazolam or Tramadol

Status Completed

Clinical Trial 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.

Clinical Trial Description

The Outcome Measures are number of Participants with Adverse Events, and the incidence of Postoperative cognitive dysfunction assessed by MMT (mini-mental test) in first 60 minutes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Chronic Disease

Clinical Trial Details

NCT number	NCT02436980
Study type	Interventional
Source	Karadeniz Technical University
Contact
Status	Completed
Phase	Phase 4
Start date	January 2009
Completion date	December 2009

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