Clonidine Versus Midazolam for Premedication - Full Text View

Sponsored by:	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:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Anxiety Surgery

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

Keywords provided by University of Schleswig-Holstein:

bispectral index
sedation
stress hormones
cognitive function

Study placed in the following topic categories:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Clonidine
Psychotropic Drugs
Adjuvants, Immunologic
Central Nervous System Depressants
Stress
Anesthetics

Pain
Cardiovascular Agents
Midazolam
Antihypertensive Agents
Hormones
Adrenergic Agonists
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Adrenergic Agonists
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Anesthetics, Intravenous
Sympatholytics
Adrenergic alpha-Agonists

Tranquilizing Agents
Clonidine
Central Nervous System Depressants
Cardiovascular Agents
Midazolam
Antihypertensive Agents
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Autonomic Agents
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009