Clonidine Versus Midazolam for Premedication

NCT00638729 | Completed

• 1 other identifier: A 157/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Pain

Keywords

bispectral index; sedation; stress hormones; cognitive function

Outcome Measures

Primary Outcomes (1)

• Effect of premedication on bispectral index

  prior study medication until 2 h postoperatively

Secondary Outcomes (1)

• Effect of premedication on postoperative recovery

  prior to study medication until 2 h postoperatively

Study Arms (3)

Midazolam

ACTIVE COMPARATOR

Pre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time

Drug: midazolam

Clonidine

ACTIVE COMPARATOR

pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time

Drug: clonidine

Placebo

PLACEBO COMPARATOR

Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time

Drug: placebo

Interventions

midazolam DRUG

midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time

Also known as: Dormicum

Midazolam

clonidine DRUG

pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time

Also known as: Catapresan

Clonidine

placebo DRUG

inert tablet p.o., 60-90 min prior to estimated induction time

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective surgery
• ASA physical status I and II
• informed consent
• weight 50 - 100 kg

You may not qualify if:

• cardiovascular disease
• pregnancy
• problems of consent due to mentally handicap or language.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Related Publications (7)

• 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. doi: 10.1097/00000539-200010000-00011.

  PMID: 11004033 BACKGROUND

• 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. doi: 10.1213/00000539-199111000-00021.

  PMID: 1683183 BACKGROUND

• 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. doi: 10.1097/00000542-198601000-00007.

  PMID: 3942335 BACKGROUND

• Grottke O, Muller 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. doi: 10.1055/s-2003-45396. German.

  PMID: 14666440 BACKGROUND

• Liu J, Singh H, White PF. Electroencephalogram bispectral analysis predicts the depth of midazolam-induced sedation. Anesthesiology. 1996 Jan;84(1):64-9. doi: 10.1097/00000542-199601000-00007.

  PMID: 8572355 BACKGROUND

• Brosius KK, Bannister CF. Oral midazolam premedication in preadolescents and adolescents. Anesth Analg. 2002 Jan;94(1):31-6, table of contents. doi: 10.1097/00000539-200201000-00006.

  PMID: 11772796 BACKGROUND

• Lindahl SG. The use of midazolam in premedication. Acta Anaesthesiol Scand Suppl. 1990;92:79-83; discussion 107. doi: 10.1111/j.1399-6576.1990.tb03191.x.

  PMID: 2183537 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Midazolam; Clonidine

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Jens Scholz, M.D.

  Chair of the Dept. of Anaesthesiology and Intensive Care Medicine, University of Schleswig-Holstein Campus Kiel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: August 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 19, 2008

Record last verified: 2008-02

Locations

DE (1)