Clinical trial NCT03697057: 4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
Official title: Computerised 4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: postoperative recovery
psychomotor function
measurement
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients scheduled for ambulatory gynaecologic surgery were asked to participate in the study during the routine informed consent process for anaesthesia. The inclusion criteria are listed in previous Section. A group of healthy female volunteers, meeting the eligibility criteria, completed the same study procedure without a surgery at three matched time points; none of them was taking any medication at the time of the study. Written informed consent was obtained from all individuals.

Brief summary: The recovery of patients after general anaesthesia is usually estimated by using clinical signs and scores. Since there is a lack of the agreed objective methods for assessing cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim of this study was to evaluate three psychological tests for this purpose. Patients, who were scheduled for ambulatory gynaecological surgery, underwent 3 standard psychological tests before (T1), 15 minutes after the surgery (T2) and on discharge from the recovery room (T3). The tests used were Wechsler memory scale (test 1, working memory capacity), d2 - test (test 2, concentration endurance) and computer-based 4-choice-reaction time (4CRT, test 3, reaction time) as well as Postanesthesia Discharge Scoring System (PADSS). The same test battery was used in healthy female volunteers, all test results were compared at the different time points.


Eligibility criteria: Inclusion Criteria:

* consecutive patients scheduled for ambulatory gynaecologic surgery
* age of 18 to 60 years
* a physical status I-II according to American Society of Anesthesiologists (ASA) classification
* fluency in German language and the ability to perform all tests

Exclusion Criteria:

* chronic consume of analgesics, psychotropic drugs, sedatives or alcohol
* if the ambulatory surgery lasted more than 60 minutes
* if the schema of standardised general anaesthesia was changed
* if the ambulatory setting was changed and the patients unexpectedly remained over night in the hospital.

Primary outcomes:
measure: 4CRT_15_min
timeFrame: 15 minutes after the end of surgery
Secondary outcomes:
measure: PADSS (Patient Discharge Scoring System)
timeFrame: Measured 60 minutes after the end of surgery
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
Study officials:
affiliation: University Medicine of Greifswald
name: Thomas Hesse, MD
role: PRINCIPAL_INVESTIGATOR
References: