Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

Study Overview
=================
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.

Official Title
-----------------
Measurement of Psychomotor Function Recovery in Patients After General Anesthesia Using 4-Choice Reaction Time Test

Conditions
-----------------
Delayed Recovery From Anaesthesia

Intervention / Treatment
-----------------
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard therapy group<br>Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery | |
| Experimental: Midazolam group<br>Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery | Drug: Midazolam<br>* The participants receive the pharmacological premedication before the surgery anyway<br>* Other names: Dormicum;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of four choice reaction time from baseline | One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant | One time before the surgery and 2 hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of midazolam in serum |  | Within 2 hours after the surgery only in 40 (20 from each group) participants |