Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

University Medicine Greifswald

Status and phase: Completed; Phase 2

Conditions: Delayed Recovery From Anaesthesia

Treatments: Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02232139

BR-87/13-1

EK-BR-87/13-1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Standard therapy group

No Intervention group

Description:

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

Midazolam group

Experimental group

Description:

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

Treatment:

Drug: Midazolam