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Completed

NCT Number: NCT03697057

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University Medicine of Greifswald

Greifswald, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General anaesthesia

Procedure

Standard general anaesthesia for gynecologic surgery in patient group

Primary outcomes

  1. 4CRT_15_min

    Time frame: 15 minutes after the end of surgery

    Change of four choice reaction time (4CRT) at 15 minutes after surgery from baseline

Secondary outcomes

  1. PADSS (Patient Discharge Scoring System)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: 4CRT_Ane

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 5, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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