Skip to main content
OpenTrials
Completed

NCT Number: NCT02232139

Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delayed Recovery From Anaesthesia Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

19 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy

Dresden, Saxony, 01067, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

The participants receive the pharmacological premedication before the surgery anyway

Other names: Dormicum

Primary outcomes

  1. Change of four choice reaction time from baseline

    Time frame: 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 outcomes

  1. Concentration of midazolam in serum

    Time frame: Within 2 hours after the surgery only in 40 (20 from each group) participants

Other outcomes

  1. Postanesthesia discharge scoring system

    Time frame: Within 2 hours after the surgery

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany

Registry information

Official study title

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

Acronym: 4CRT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2014
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.