Clonidine Versus Midazolam for Premedication - Full Text View

Sponsor:	University of Schleswig-Holstein
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00638729

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Clonidine Clonidine hydrochloride

U.S. FDA Resources

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

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:

Matot I, Sichel JY, Yofe V, Gozal Y. The effect of clonidine premedication on hemodynamic responses to microlaryngoscopy and rigid bronchoscopy. Anesth Analg. 2000 Oct;91(4):828-33.

Carabine UA, Milligan KR, Moore JA. Adrenergic modulation of preoperative anxiety: a comparison of temazepam, clonidine, and timolol. Anesth Analg. 1991 Nov;73(5):633-7.

Ghignone M, Quintin L, Duke PC, Kehler CH, Calvillo O. Effects of clonidine on narcotic requirements and hemodynamic response during induction of fentanyl anesthesia and endotracheal intubation. Anesthesiology. 1986 Jan;64(1):36-42.

Grottke O, Müller J, Dietrich PJ, Krause TH, Wappler F. [Comparison of premedication with clonidine and midazolam combined with TCI for orthopaedic shoulder surgery] Anasthesiol Intensivmed Notfallmed Schmerzther. 2003 Dec;38(12):772-80. German.

Liu J, Singh H, White PF. Electroencephalogram bispectral analysis predicts the depth of midazolam-induced sedation. Anesthesiology. 1996 Jan;84(1):64-9.

Brosius KK, Bannister CF. Oral midazolam premedication in preadolescents and adolescents. Anesth Analg. 2002 Jan;94(1):31-6, table of contents.

Lindahl SG. The use of midazolam in premedication. Acta Anaesthesiol Scand Suppl. 1990;92:79-83; discussion 107. Review.

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
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on February 09, 2012