4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia (4CRT_Ane)

Computerised 4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: General anaesthesia

• Study Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany
    • University Medicine of Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients; Patients scheduled for elective ambulatory gynaecological surgery, which was performed under standardised general anaesthesia	Procedure: General anaesthesia; Standard general anaesthesia for gynecologic surgery in patient group
healthy volunteers; Female healthy volunteers matched to the patient group regarding the age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4CRT_15_min	Change of four choice reaction time (4CRT) at 15 minutes after surgery from baseline	15 minutes after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PADSS (Patient Discharge Scoring System)	Post Anaesthetic Discharge Scoring System (PADSS) is a clinically-based, objective scoring system used to measure the home readiness of patients following day surgery. PADSS consists of six criteria: ambulation, circulation (blood pressure monitoring), nausea/vomiting, pain and surgical bleeding bleeding. Each criterion is given a score ranging from 0 to 2, maximal score is 10. Only patients who achieve a score of 9 or more are considered ready for discharge.	Measured 60 minutes after the end of surgery

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Thomas Hesse, MD, University Medicine of Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: measurement; postoperative recovery; psychomotor function
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: III UV 03/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will send the IPD on request via email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No