Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000435482
Ethics application status
Approved
Date submitted
21/08/2007
Date registered
29/08/2007
Date last updated
25/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of beachchair position on cerebral blood flow during shoulder arthroscopy
Scientific title
The effect of beachchair position on cerebral blood flow during shoulder arthroscopy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral blood flow during anaesthesia 2281 0
Condition category
Condition code
Anaesthesiology 2375 2375 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effects of the beach chair position during shoulder surgery on cerebral blood flow, with either regional or general anaesthesia. The duration of intervention is 1 hour. The sedation will be with midazolam 1-5mg and fentanyl 10-100mcg. general anaesthesia will be induced with propofol 50-200mg and maintained on sevoflurane 2-4%.
Intervention code [1] 1994 0
Treatment: Other
Comparator / control treatment
General anaesthesia versus sedation
Control group
Active

Outcomes
Primary outcome [1] 3272 0
Cerebral blood flow in the beach chair position
Timepoint [1] 3272 0
From supine position to beach chair position
Secondary outcome [1] 5456 0
Intravenous fluid requirements
dose of vasopressor
Timepoint [1] 5456 0
End of anaesthetic

Eligibility
Key inclusion criteria
>18 years
able to provide informed consent
shoulder surgery suitable for beach chair position
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Previous cerebrovascular accident
Current cardiac disease including pacemaker
Prior carotid endarterectomy
Contraindications to interscalene block

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent followed by opening of sealed envelopes. Underlined the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Equal numbers of randomisation pairs, shuffled and assigned to sealed envelopes by an independent person.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 379 0
3181

Funding & Sponsors
Funding source category [1] 2533 0
University
Name [1] 2533 0
The University of Melbourne
Country [1] 2533 0
Australia
Primary sponsor type
Hospital
Name
The Avenue Hospital
Address
40 the Avenue
Windsor, Victoria, 3181
Country
Australia
Secondary sponsor category [1] 2292 0
None
Name [1] 2292 0
Address [1] 2292 0
Country [1] 2292 0
Other collaborator category [1] 15 0
University
Name [1] 15 0
The University of Melbourne
Address [1] 15 0
Carlton, Victoria, 3010
Country [1] 15 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4448 0
The Avenue Hospital HREC
Ethics committee address [1] 4448 0
40 the Avenue
Windsor, Victoria, 3181
Ethics committee country [1] 4448 0
Date submitted for ethics approval [1] 4448 0
Approval date [1] 4448 0
04/07/2007
Ethics approval number [1] 4448 0
HREC# 084

Summary
Brief summary
Shoulder arthroscopy, or keyhole surgery of the shoulder, has been an accepted form of surgery for many years. The surgery can be performed with the patient sitting upright (beachchair position), or lying on their side. Both techniques have been performed successfully for many years. The choice is usually dependent on the professional experience and preference of the surgeon. One of the research investigators, typically performs this surgery in the upright position.
Some medical professionals are of the opinion that performing shoulder arthroscopy in the upright position, can affect flow of blood to the brain. This is not something that has been conclusively demonstrated by research to date.
We use a technique of anaesthesia that we believe is very safe and is used widely throughout the world. Further, we are of the opinion that it does not adversely affect flow of blood to the brain.
The surgery will be performed using the anaesthetic technique that we use for the majority of the surgeon’s cases. The patient will receive a nerve block that will anaesthetise the arm receiving surgery. This will be combined with either a general anaesthetic or intravenous sedation. We will use an ultrasound probe to monitor the flow of blood in the major arteries in the patient’s neck. This will give us an indication of the flow of blood to the brain.
The increased monitoring will ensure patient safety during the procedure, as we will be able to detect previously unknown side-to-side differences in blood flow in the individual patients. The research will help us prove to others unfamiliar with the technique, that it is safe for this surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27995 0
Address 27995 0
Country 27995 0
Phone 27995 0
Fax 27995 0
Email 27995 0
Contact person for public queries
Name 11152 0
Dr Paul Soeding
Address 11152 0
Cardiovascular therapeutics unit
level 8, medical sciences building
University of Melbourne, Carlton, Victoria, 3010
Country 11152 0
Australia
Phone 11152 0
+ 61383445673
Fax 11152 0
Email 11152 0
[email protected]
Contact person for scientific queries
Name 2080 0
Dr Paul Soeding
Address 2080 0
level 8, medical sciences building
University of Melbourne, Carlton, Victoria, 3010
Country 2080 0
Australia
Phone 2080 0
+ 61383445673
Fax 2080 0
Email 2080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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