Skip to main content
OpenTrials
Completed

NCT Number: NCT02436980

Premedication for ERCP With Midazolam or Tramadol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tramadol

Drug

GROUP T

Other names: CONTRAMAL

midazolam

Drug

GROUP M

Other names: DORMICUM

Primary outcomes

  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 outcomes

  1. Number of Participants with Adverse Events

    Time frame: Postprocedure in first 60 minutes

    With any side effects

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 7, 2015
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.