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

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ClinicalTrials.gov Identifier: NCT03697057
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Study Description
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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.

Condition or disease Intervention/treatment
Postoperative Complications Procedure: General anaesthesia

Study Design
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Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Computerised 4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
Actual Study Start Date : March 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697057


Locations
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Germany
University Medicine of Greifswald
Greifswald, Germany
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Principal Investigator: Thomas Hesse, MD University Medicine of Greifswald
More Information
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03697057    
Other Study ID Numbers: III UV 03/05
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will send the IPD on request via email.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medicine Greifswald:
postoperative recovery
psychomotor function
measurement
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs