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CompletedPhase 3ACTRN12605000150640

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

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.

Sponsor

Dr. Brendan Silbert

Enrollment

200 participants

Start Date

Jul 11, 2005

Study Type

Interventional

Conditions

Post Operative Cognitive Dysfunction (POCD)

Eligibility

Sex: Both males and femalesMin Age: 55 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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Interventions

To study patients undergoing a single surgical treatment: extracorporeal shock wave lithotripsy (ESWL) for treatment of kidney stones. General anaesthesia will consist of routine clinical practice usi

To study patients undergoing a single surgical treatment: extracorporeal shock wave lithotripsy (ESWL) for treatment of kidney stones. General anaesthesia will consist of routine clinical practice using midazolam/fentanyl/propofol/laryngeal mask/spontaneous respiration of air and oxygen. Regional anaesthesia will conform to current practice consisting of #25 gauge spinal needle and 0.5% heavy spinal marcaine. Patients will complete a neuropyschological test battery preoperatively, 7 days and 3 months postoperatively and a short test version at discharge.

Locations(1)

Australia

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ACTRN12605000150640