Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Effect of premedication on bispectral index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Midazolam
Pre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
Intervention: midazolam (Drug)
Clonidine
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
Intervention: clonidine (Drug)
Placebo
Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time
Intervention: placebo (Drug)
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(prior to study medication until 2 h postoperatively)