Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Premedication for ERCP With Midazolam or Tramadol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436980
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : May 13, 2015
Sponsor:
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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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
GROUP T
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.
Drug: Midazolam
GROUP M
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Investigators
Layout table for investigator information
Study Chair: Mehmet Arslan, Prof.Dr. Gastroenterology Department

Layout table for additonal information
Responsible Party: Hulya ULUSOY, Assoc.Prof.Dr., Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT02436980     History of Changes
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:
premedication
ERCP
midazolam
tramadol
cognitive
Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
Chronic Disease
Disease Attributes
Pathologic Processes
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents