Anxiety
Conditions
Keywords
Premedication, Benzodiazepine, Anti-anxiety agents, Anxiety, Surgery, Adult, Human
Brief summary
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients. * one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery * one receiving zopiclone (7.5 mg) before sleep and placebo at awakening * one receiving placebo before sleep and alprazolam (0.5 mg)at awakening double blind, randomized controlled study
Detailed description
Eligibility: * 18 to 65 years old * elective surgery * in-hospital preoperative night Outcome measures: * anxiety scales * demographic data
Interventions
DRUGZopiclone
7.5 mg before sleep, the evening before surgery
DRUGAlprazolam
0.5 mg at awakening, the day of surgery
DRUGplacebo
given night before surgery and at awakening, the day of surgery
Sponsors
University Hospital, Angers
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 65 Years
Healthy volunteers
No
Inclusion criteria
* age 18-65 years old * elective surgery * in-hospital night before surgery
Exclusion criteria
* myasthenia gravis * chronic intake of psychotropic drugs * opiates intake * severe obstructive sleep apnea * intracranial hypertension * morbid obesity * myasthenia gravis * acute severe medical disorder * non health insurance coverage * protected patients by law * pregnancy * non French speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anxiety scales | duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room) | \* The day before surgery (late afternoon) : patient's self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS) \* On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the anxiety component of the APAIS scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| markers of stress | on arrival to operating room (one single recording) | recording of actual (using the operating room monitor): * heart rate (at rest, supine) * systolic blood pressure (at rest, supine) |
Countries
France
Outcome results
None listed