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

Primary Purpose

Delayed Recovery From Anaesthesia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Midazolam
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delayed Recovery From Anaesthesia

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard therapy group

Midazolam group

Arm Description

Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery

Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Concentration of midazolam in serum

Full Information

First Posted
August 28, 2014
Last Updated
January 8, 2021
Sponsor
University Medicine Greifswald
Collaborators
Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02232139
Brief Title
Measurement of Psychomotor Recovery After Anesthesia Using 4CRT
Acronym
4CRT
Official Title
Measurement of Psychomotor Function Recovery in Patients After General Anesthesia Using 4-Choice Reaction Time Test
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
Collaborators
Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Recovery From Anaesthesia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy group
Arm Type
No Intervention
Arm Description
Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery
Arm Title
Midazolam group
Arm Type
Experimental
Arm Description
Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
The participants receive the pharmacological premedication before the surgery anyway
Primary Outcome Measure Information:
Title
Change of four choice reaction time from baseline
Description
One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant
Time Frame
One time before the surgery and 2 hours after the surgery
Secondary Outcome Measure Information:
Title
Concentration of midazolam in serum
Time Frame
Within 2 hours after the surgery only in 40 (20 from each group) participants
Other Pre-specified Outcome Measures:
Title
Postanesthesia discharge scoring system
Time Frame
Within 2 hours after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras I Usichenko, MD, PhD
Organizational Affiliation
University Medicine of Greifswald
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01067
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
2596654
Citation
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.
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Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

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