Premedication for ERCP With Midazolam or Tramadol

Phase 4

Completed

• Conditions: Chronic Disease
• Interventions: Drug: Tramadol; Drug: Midazolam

• Registration Number: NCT02436980
• Lead Sponsor: Karadeniz Technical University

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-01
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Study First Submitted: 2015-04-27
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-07
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tramadol	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.
midazolam	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.

Primary Outcome Measures

Name	Time	Method
The early cognitive functions after ERCP	Postprocedure in the first 60 minutes	The early cognitive functions after ERCP assessed by mini-mental test (MMT)

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Postprocedure in first 60 minutes	With any side effects