Anxiety
Conditions
Keywords
premedication, preoperative anxiety, salivary cortisol level, anxiety visual analog scale
Brief summary
Preoperative anxiety is a subjective and painful experience and may have adverse psychological consequences and complicate anesthetic management. The aim of the study is to show the effect of premedication by midazolam on preoperative anxiety assessed by a visual analog scale and by measuring salivary cortisol levels. This study was a monocentric, prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to 79 years, to undergo elective surgery under general anesthesia with tracheal intubation must be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of respiratory and hemodynamic adverse effects of midazolam.
Interventions
DRUGplacebo administration
DRUGmidazolam intravenous administration
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* major patient undergoing elective surgery under general anesthesia with tracheal intubation * Anesthesia state 1 and 2 * preoperative fasting for 6 hours * information and signed consent * social security * non pregnant women
Exclusion criteria
* anesthesia state above 3 * midazolam sensibility * pregnant or breastfeeding women * ICU patients * no consent * pediatric surgery * no social security * no tracheal intubation * required premedication in placebo group or midazolam sensibility in premedication group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale of anxiety | baseline, up to the end of support in recovery room | visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global anxiety | baseline | rated from 4 to 20 for global anxiety and from 2 to 10 for information request anxiety is high above 10 for women and 12 for men |
| Patient's satisfaction | at the end of the support in recovery room | rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room |
| Intraoperative consumption of hypnotics and opioids | at anesthesia induction up to 10 minutes | Cumulative dose of hypnotics and opioids reduced to dose per kilogram |
| salivary cortisol level | baseline and at the entrance in operating room | biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes) |
| Intubation score | after intubation | Rated from 1 bed conditions for intubation to 5 for excellent conditions |
| Adverse midazolam effects | baseline up to the end of support in recovery room | assessed by variations of arterial pressure, heart rate, respiratory rate, oxygen saturation and end tidal of carbon dioxide for hemodynamics and respiratory adverse effects assessed by Observer's assessment of alertness/sedation for deep of sedation rated from 1 sleeping patient to 5 for awake patient |
| Output score of recovery room (Aldrete score) | at the end of support in recovery room | rated from 0 to 10 essential for the output of recovery room |
| Comfort induction | at anesthesia induction | rated from 1 for deep discomfort to 5 for good comfort |
Countries
France
Outcome results
None listed