Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000150640
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
15/08/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Date results information initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is regional anaesthesia associated with postoperative cognitive deficit? A prospective randomised controlled trial.
Scientific title
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.
Secondary ID [1] 299814 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The GRAIL Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Operative Cognitive Dysfunction (POCD) 241 0
Condition category
Condition code
Mental Health 272 272 0 0
Studies of normal psychology, cognitive function and behaviour
Anaesthesiology 273 273 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 157 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 322 0
Freqeuncy of POCD
Timepoint [1] 322 0
At 7 days and 3 months postoperatively.
Secondary outcome [1] 722 0
Quality of life
Timepoint [1] 722 0
At 3 months.

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope to anaesthetist immediately prior to procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence will be generated by computer software PC_PLAN. The restriction method will be random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/11/2005
Actual
11/07/2005
Date of last participant enrolment
Anticipated
Actual
25/07/2011
Date of last data collection
Anticipated
Actual
27/10/2011
Sample size
Target
200
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 328 0
Other Collaborative groups
Name [1] 328 0
Australia and New Zealand College of Anaesthetists
Country [1] 328 0
Primary sponsor type
Individual
Name
Dr. Brendan Silbert
Address
Country
Secondary sponsor category [1] 259 0
Individual
Name [1] 259 0
A/Prof. David Scott
Address [1] 259 0
Country [1] 259 0
Secondary sponsor category [2] 260 0
Individual
Name [2] 260 0
A/Prof. Paul Maruff
Address [2] 260 0
Country [2] 260 0
Secondary sponsor category [3] 261 0
Individual
Name [3] 261 0
Ms. Lis Evered
Address [3] 261 0
Country [3] 261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1263 0
St. Vincent's Hospital Melbourne
Ethics committee address [1] 1263 0
Ethics committee country [1] 1263 0
Australia
Date submitted for ethics approval [1] 1263 0
Approval date [1] 1263 0
01/11/2004
Ethics approval number [1] 1263 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Silbert, B. S., Evered, L. A., & Scott, D. A. (2014). Incidence of postoperative cognitive dysfunction after general or spinal anaesthesia for extracorporeal shock wave lithotripsy. British Journal of Anaesthesia, 113(5), 784-791. doi: 10.1093/bja/aeu163
Public notes

Contacts
Principal investigator
Name 35792 0
Address 35792 0
Country 35792 0
Phone 35792 0
Fax 35792 0
Email 35792 0
Contact person for public queries
Name 9346 0
Dr. Brendan Silbert
Address 9346 0
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 9346 0
Australia
Phone 9346 0
+61 3 92884253
Fax 9346 0
+61 3 92884255
Email 9346 0
[email protected]
Contact person for scientific queries
Name 274 0
Ms. Lis Evered
Address 274 0
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 274 0
Australia
Phone 274 0
+61 3 92882251
Fax 274 0
+61 3 92884255
Email 274 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.