Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

NCT ID: NCT02232139

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-06-25

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.

Conditions

Delayed Recovery From Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard therapy group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Midazolam group

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

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

The participants receive the pharmacological premedication before the surgery anyway

Interventions

Midazolam

The participants receive the pharmacological premedication before the surgery anyway

Intervention Type: DRUG

Other Intervention Names

Dormicum

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taras I Usichenko, MD, PhD

Role: STUDY_DIRECTOR

University Medicine of Greifswald

Locations

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

Dresden, Saxony, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 2596654 (View on PubMed)

Other Identifiers

EK-BR-87/13-1

Identifier Type: OTHER

Identifier Source: secondary_id

BR-87/13-1

Identifier Type: -

Identifier Source: org_study_id