Is regional anaesthesia associated with postoperative cognitive deficit? A prospective randomised controlled trial.

Phase 3

Completed

• Conditions: Post Operative Cognitive Dysfunction (POCD); Mental Health - Studies of normal psychology, cognitive function and behaviour; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12605000150640
• Lead Sponsor: Dr. Brendan Silbert

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients who are scheduled for elective ESWL, do not have neurological deficit, give written informed consent and have no contraindication to neuropsychological testing. The patients must reside in accessible proximity to the hospital to enable investigators to administer testing at home.

Exclusion Criteria

1. Pre-existing neurological or neurovascualr disease (eg. stroke); 2. Score of less than 24 on the Mini Mental State Examination (MMSE); 3. Anticipated difficulty with neuropsychologcail assessment such as English not being the prime language, blindness, deafness; 4. Associated medical problems that may lead to significant complications and subsequent loss to follow-up (ASA Physical Status IV or higher); 5. Contraindication to spinal anaesthesia (eg. anti-coagulation therapy or bleeding tendency); 6. Body Mass Index (BMI) greater than 35.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freqeuncy of POCD[At 7 days and 3 months postoperatively.]

Secondary Outcome Measures

Name	Time	Method
Quality of life[At 3 months.]