Clonidine Versus Midazolam for Premedication - Tabular View

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

March 18, 2008

Start Date ^ICMJE

August 2005

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effect of premedication on bispectral index [ Time Frame: prior study medication until 2 h postoperatively ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect of premedication on postoperative recovery [ Time Frame: prior to study medication until 2 h postoperatively ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clonidine Versus Midazolam for Premedication

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Anxiety
Pain

Intervention ^ICMJE

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

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

Other Name: Catapresan
Drug: placebo
inert tablet p.o., 60-90 min prior to estimated induction time

Study Arms / Comparison Groups

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

Intervention: Drug: midazolam
Clonidine: Active Comparator
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time

Intervention: Drug: clonidine
Placebo: Placebo Comparator
Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time

Intervention: Drug: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00638729

Responsible Party

Prof. Dr. J. Scholz, Chair of the Department of Anaesthesiology and Intensive Care Medicine, University Schleswig-Holstein Campus Kiel

Study ID Numbers ^ICMJE

A 157/01, A 157/01

Study Sponsor ^ICMJE

University of Schleswig-Holstein

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Jens Scholz, M.D.

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

Information Provided By

University of Schleswig-Holstein

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP