Clonidine Versus Midazolam for Premedication

Overview

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.

Full Title of Study: “Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: March 2007

Interventions

  • 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

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Effect of premedication on bispectral index
    • 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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Schleswig-Holstein
  • Provider of Information About this Clinical Study
    • Prof. Dr. J. Scholz, Chair of the Department of Anaesthesiology and Intensive Care Medicine, University Schleswig-Holstein Campus Kiel
  • Overall Official(s)
    • Jens Scholz, M.D., Study Chair, Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.