Clonidine Versus Midazolam for Premedication

NCT ID: NCT00638729

Last Updated: 2008-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Pain

Keywords

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bispectral index sedation stress hormones cognitive function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Midazolam

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

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

clonidine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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midazolam

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

Intervention Type DRUG

clonidine

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Dormicum Catapresan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Jens Scholz, M.D.

Role: STUDY_CHAIR

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

Locations

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

Kiel, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 11004033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1683183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3942335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14666440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8572355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11772796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2183537 (View on PubMed)

Other Identifiers

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A 157/01

Identifier Type: -

Identifier Source: secondary_id

A 157/01

Identifier Type: -

Identifier Source: org_study_id