Clonidine Versus Midazolam for Premedication

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00638729
First received: March 12, 2008
Last updated: March 18, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention
Anxiety
Pain
Drug: midazolam
Drug: clonidine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Effect of premedication on bispectral index [ Time Frame: prior study medication until 2 h postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of premedication on postoperative recovery [ Time Frame: prior to study medication until 2 h postoperatively ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00638729

Locations
Germany
Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
University of 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
  More Information

Publications:
Responsible Party: Prof. Dr. J. Scholz, Chair of the Department of Anaesthesiology and Intensive Care Medicine, University Schleswig-Holstein Campus Kiel
ClinicalTrials.gov Identifier: NCT00638729     History of Changes
Other Study ID Numbers: A 157/01, A 157/01
Study First Received: March 12, 2008
Last Updated: March 18, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
bispectral index
sedation
stress hormones
cognitive function

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anesthetics
Midazolam
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 28, 2014