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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
GROUP T
GROUP M
The early cognitive functions after ERCP
The early cognitive functions after ERCP assessed by mini-mental test (MMT)
Time frame: Postprocedure in the first 60 minutes
Number of Participants with Adverse Events
With any side effects
Time frame: Postprocedure in first 60 minutes
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