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Completed

NCT Number: NCT00638729

Clonidine Versus Midazolam for Premedication

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kiel, 24105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

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

Other names: Dormicum

Clonidine

Drug

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

Other names: Catapresan

Placebo

Drug

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

Primary outcomes

  1. Effect of premedication on bispectral index

    Time frame: prior study medication until 2 h postoperatively

Secondary outcomes

  1. Effect of premedication on postoperative recovery

    Time frame: prior to study medication until 2 h postoperatively

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 19, 2008
Registry last updated
Mar 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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