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

Completed

• Conditions: Postoperative Complications
• Interventions: Procedure: General anaesthesia

• Registration Number: NCT03697057
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2018-10
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-04
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients	General anaesthesia	Patients scheduled for elective ambulatory gynaecological surgery, which was performed under standardised general anaesthesia

Primary Outcome Measures

Name	Time	Method
4CRT_15_min	15 minutes after the end of surgery	Change of four choice reaction time (4CRT) at 15 minutes after surgery from baseline

Secondary Outcome Measures

Name	Time	Method
PADSS (Patient Discharge Scoring System)	Measured 60 minutes after the end of surgery	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.

Trial Locations

Locations (1)

University Medicine of Greifswald; 🇩🇪 Greifswald, Germany