Delayed Recovery From Anaesthesia
Conditions
Brief summary
The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients will be monitored using 4CRT before and after standardized general anesthesia. The reaction time, measured with 4CRT is the primary outcome parameter of the investigation.
Detailed description
4CRT is a classical psychological test, used to measure the psychomotor speed. This test measures choice reaction time. The participants are instructed to respond by pressing the keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is usually taken as 4CRT outcome.
Interventions
DRUGMidazolam
The participants receive the pharmacological premedication before the surgery anyway
Sponsors
Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Physical status I-III according to American Society of Anesthesiology * ambulatory gynecologic surgery of 10-40 min * patient is able to use VAS and to use SmartPhone-based 4CRT * given informed consent
Exclusion criteria
* age \< 18 or \> 50 years * patients who are not able to give their informed consent * surgery lasts more than 40 min. * history of psychopharmaceuticals or analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of four choice reaction time from baseline | One time before the surgery and 2 hours after the surgery | One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of midazolam in serum | Within 2 hours after the surgery only in 40 (20 from each group) participants |
Other
| Measure | Time frame |
|---|---|
| Postanesthesia discharge scoring system | Within 2 hours after the surgery |
Countries
Germany
Outcome results
None listed