Measurement of Psychomotor Recovery After Anesthesia Using 4CRT (4CRT)

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

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.

Study Overview

• Status: Completed
• Conditions: Delayed Recovery From Anaesthesia
• Intervention / Treatment: Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01067
      • Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard therapy group; Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery
Experimental: Midazolam group; Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery	Drug: Midazolam; The participants receive the pharmacological premedication before the surgery anyway; 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	Time Frame
Concentration of midazolam in serum	Within 2 hours after the surgery only in 40 (20 from each group) participants

Other Outcome Measures

Outcome Measure	Time Frame
Postanesthesia discharge scoring system	Within 2 hours after the surgery

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany
• Investigators: Study Director: Taras I Usichenko, MD, PhD, University Medicine of Greifswald

Publications and helpful links

General Publications

• Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): June 25, 2019

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 5, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: BR-87/13-1; EK-BR-87/13-1 (Other Identifier: Ethics commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No