Clonidine Versus Midazolam for Premedication
Information source: University of Schleswig-Holstein
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety; Pain
Intervention: midazolam (Drug); clonidine (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Schleswig-Holstein Official(s) and/or principal investigator(s):
Jens Scholz, M.D., Study Chair, Affiliation: Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel
Summary
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.
Clinical Details
Official title: Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Effect of premedication on bispectral index
Secondary outcome: Effect of premedication on postoperative recovery
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel, Kiel 24105, Germany
Additional Information
Related 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.
Starting date: August 2005
Last updated: March 18, 2008
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