Premedication for ERCP With Midazolam or Tramadol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Midazolam or Tramadol Premedication on Early Cognitive Function in ERCP: a Randomized Controlled Double-Blind Study

Conditions
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Chronic Disease

Intervention / Treatment
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* Drug: Tramadol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study was conducted in the Endoscopy Department for forty (18-70 years old) outpatients in ASA I-III risk group were randomized and double blind planned for elective ERCP. Exclusion Criteria: American Society of Anesthesiologist (ASA) class greater than 3, morbid obesity, major organ dysfunction (respiratory, renal and hepatic), history of drug addiction, known hypersensitivity for tramadol, midazolam and remifentanil, mini-mental test (MMT) ≤ 23 or refusal of the patient.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tramadol<br>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. | Drug: Tramadol<br>* GROUP T<br>* Other names: CONTRAMAL;|
| Active Comparator: midazolam<br>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. | Drug: Midazolam<br>* GROUP M<br>* Other names: DORMICUM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The early cognitive functions after ERCP | The early cognitive functions after ERCP assessed by mini-mental test (MMT) | Postprocedure in the first 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | With any side effects | Postprocedure in first 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premedication, ERCP, midazolam, tramadol, cognitive