Premedication for ERCP With Midazolam or Tramadol
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|ClinicalTrials.gov Identifier: NCT02436980|
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : May 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease||Drug: Tramadol Drug: Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Midazolam or Tramadol Premedication on Early Cognitive Function in ERCP: a Randomized Controlled Double-Blind Study|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: tramadol
1mg/kg of tramadol drop (Contramal® drop, Abdi Ibrahim Ilaç San.,istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, Group T who were separated randomly to two premedication groups.
Other Name: CONTRAMAL
Active Comparator: midazolam
0.15 mg/kg of midazolam (Dormicum®, ampoule, Roche Products A.Ş., istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, to Group M who were separated randomly to two premedication groups.
Other Name: DORMICUM
- The early cognitive functions after ERCP [ Time Frame: Postprocedure in the first 60 minutes ]The early cognitive functions after ERCP assessed by mini-mental test (MMT)
- Number of Participants with Adverse Events [ Time Frame: Postprocedure in first 60 minutes ]With any side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436980
|Study Chair:||Mehmet Arslan, Prof.Dr.||Gastroenterology Department|