ACTRN12605000150640CompletedPhase 3
The prospective randomised controlled phase III GRAIL Trial will consider patients receiving general anaesthesia compared to those receiving regional anaesthesia to undergo extracorporeal shock wave lithotripsy for the treatment of kidney stones and will evaluate whether there is any difference in the incidence of postoperative cognitive dysfunction (POCD) in the short and medium term.
Dr. Brendan Silbert0 sites200 target enrollmentStarted: August 15, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 55 Years to ot stated (—)
- Sex
- All
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.
Investigators
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