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

Postoperative Complications Clinical Trial

— 4CRT_Ane  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697057
• Other study ID #: III UV 03/05
• Status: Completed
• Start date: March 2008
• Est. completion date: April 2010

Study information

• Verified date: October 2018
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• General anaesthesia
Standard general anaesthesia for gynecologic surgery in patient group

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PADSS (Patient Discharge Scoring System)	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.	Measured 60 minutes after the end of surgery