Clonidine Versus Midazolam for Premedication

University Hospital Schleswig-Holstein60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Anxiety Pain

Interventions

midazolamDRUG

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

clonidineDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Kiel, Germany

Outcomes

Primary Outcomes

Effect of premedication on bispectral index

Time frame: prior study medication until 2 h postoperatively

Secondary Outcomes

Effect of premedication on postoperative recovery

Time frame: prior to study medication until 2 h postoperatively

Data from ClinicalTrials.gov

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