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

NCT03697057 | Completed

• 1 other identifier: III UV 03/05
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

postoperative recovery; psychomotor function; measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PADSS (Patient Discharge Scoring System)

  Measured 60 minutes after the end of surgery

Study Arms (2)

patients

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

Procedure: General anaesthesia

healthy volunteers

Female healthy volunteers matched to the patient group regarding the age

Interventions

General anaesthesia PROCEDURE

Standard general anaesthesia for gynecologic surgery in patient group

patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine of Greifswald

Greifswald, Germany

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Thomas Hesse, MD

  University Medicine of Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 5, 2018
• Study Start: March 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)