Clonidine Versus Midazolam for Premedication

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Anxiety; Pain

Treatments: Drug: placebo; Drug: midazolam; Drug: clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00638729

A 157/01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Midazolam

Active Comparator group

Description:

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

Treatment:

Drug: midazolam

Clonidine

Active Comparator group

Description:

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

Treatment:

Drug: clonidine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo