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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
Information provided by (Responsible Party):
Hulya ULUSOY, 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.

Condition or disease Intervention/treatment Phase
Chronic Disease Drug: Tramadol Drug: Midazolam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.
Drug: Tramadol

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.
Drug: Midazolam
Other Name: DORMICUM

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: Postprocedure in first 60 minutes ]
    With any side effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

Sponsors and Collaborators
Karadeniz Technical University
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Study Chair: Mehmet Arslan, Prof.Dr. Gastroenterology Department
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Responsible Party: Hulya ULUSOY, Assoc.Prof.Dr., Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT02436980    
Other Study ID Numbers: 499
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Hulya ULUSOY, Karadeniz Technical University:
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents