Clonidine Versus Midazolam for Premedication

Pain Clinical Trial

Official title:

Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638729
• Other study ID #: A 157/01
• Secondary ID: A 157/01
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: March 18, 2008
• Start date: August 2005
• Est. completion date: March 2007

Study information

• Verified date: February 2008
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Drug:
• midazolam
midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
• clonidine
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
• placebo
inert tablet p.o., 60-90 min prior to estimated induction time

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of premedication on bispectral index		prior study medication until 2 h postoperatively	No
Secondary	Effect of premedication on postoperative recovery		prior to study medication until 2 h postoperatively	No