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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000150640

Acronym

The GRAIL Trial

Enrollment

100

Registered

2005-08-15

Start date

2005-07-11

Completion date

2011-07-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 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 m

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Healthy volunteers

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.

Outcome results