Clonidine Versus Midazolam for Premedication

March 18, 2008 updated by: University Hospital Schleswig-Holstein

Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery

alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating stress hormones.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective surgery
  • ASA physical status I and II
  • informed consent
  • weight 50 - 100 kg

Exclusion Criteria:

  • cardiovascular disease
  • pregnancy
  • problems of consent due to mentally handicap or language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Midazolam
Pre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
Drug: midazolam
midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
Other Names:
  • Dormicum
Active Comparator: Clonidine
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
Drug: clonidine
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
Other Names:
  • Catapresan
Placebo Comparator: Placebo
Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time
Drug: placebo
inert tablet p.o., 60-90 min prior to estimated induction time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of premedication on bispectral index
Time Frame: prior study medication until 2 h postoperatively
prior study medication until 2 h postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of premedication on postoperative recovery
Time Frame: prior to study medication until 2 h postoperatively
prior to study medication until 2 h postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Study Chair: Jens Scholz, M.D., Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

March 19, 2008

Last Update Submitted That Met QC Criteria

March 18, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 157/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on midazolam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe