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...
Date First Received: March 12, 2008
Last Updated: March 18, 2008
Verified by: University of Schleswig-Holstein, February 2008
Clinical Trial Phase: N/A | Start Date: August 2005
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
Official Title: “Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery”
Intervention(s):
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 Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment
Study Primary Completion Date: March 2007
Intervention(s) in this Clinical Trial
- Drug: midazolam
- midazolam, 7.5 mg 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
- Drug: placebo
- inert tablet p.o., 60-90 min prior to estimated induction time
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Midazolam
- Pre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
- Active Comparator: Clonidine
- pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
- Placebo Comparator: Placebo
- Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time
Outcome Measures for this Clinical Trial
Primary Measures
- Effect of premedication on bispectral index
- Time Frame: prior study medication until 2 h postoperatively
Safety Issue?: No
- Time Frame: prior study medication until 2 h postoperatively
Secondary Measures
- Effect of premedication on postoperative recovery
- Time Frame: prior to study medication until 2 h postoperatively
Safety Issue?: No
- Time Frame: prior to study medication until 2 h postoperatively
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Schleswig-Holstein
Overall Clinical Trial Officials and Contacts
Jens Scholz, M.D. Study Chair Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638729
Study ID Number: A 157/01
ClinicalTrials.gov Identifier: NCT00638729
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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