Anxiety, Pain
Conditions
Keywords
bispectral index, sedation, stress hormones, cognitive function
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.
Interventions
DRUGmidazolam
midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time
DRUGclonidine
pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time
DRUGplacebo
inert tablet p.o., 60-90 min prior to estimated induction time
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of premedication on bispectral index | prior study medication until 2 h postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Effect of premedication on postoperative recovery | prior to study medication until 2 h postoperatively |
Countries
Germany
Outcome results
None listed