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

NCT ID: NCT03697057

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Postoperative Complications

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

Patients scheduled for elective ambulatory gynaecological surgery, which was performed under standardised general anaesthesia

General anaesthesia

Intervention Type PROCEDURE

Standard general anaesthesia for gynecologic surgery in patient group

healthy volunteers

Female healthy volunteers matched to the patient group regarding the age

No interventions assigned to this group

Interventions

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General anaesthesia

Standard general anaesthesia for gynecologic surgery in patient group

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Hesse, MD

Role: PRINCIPAL_INVESTIGATOR

University Medicine of Greifswald

Locations

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University Medicine of Greifswald

Greifswald, , Germany

Site Status

Countries

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Germany

Other Identifiers

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III UV 03/05

Identifier Type: -

Identifier Source: org_study_id

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