Clinical Trial: Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University Medicine Greifswald

Current Primary Outcome: Change of four choice reaction time from baseline [ Time Frame: One time before the surgery and 2 hours after the surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Concentration of midazolam in serum [ Time Frame: Within 2 hours after the surgery only in 40 (20 from each group) participants ]

Original Secondary Outcome: Same as current

Information By: University Medicine Greifswald

Dates:
Date Received: August 28, 2014
Date Started: March 2016
Date Completion: May 2018
Last Updated: April 3, 2017
Last Verified: April 2017