Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001075077
Ethics application status
Approved
Date submitted
16/02/2010
Date registered
7/12/2010
Date last updated
7/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac function and cerebral blood flow in the beachchair surgical patient.
Scientific title
The effect of vasopressor therapy with phenylepherine infusion versus a placebo saline infusion on cardiac function and cerebral blood flow in the beachchair surgical patient.
Secondary ID [1] 253166 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraoperative cerebral hypoperfusion 256836 0
Haemodynamic state in the Beachchair position during shoulder surgery 256837 0
Condition category
Condition code
Anaesthesiology 256983 256983 0 0
Anaesthetics
Surgery 256999 256999 0 0
Surgical techniques
Stroke 258866 258866 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effects of vasopressor therapy on cerebral blood flow and oxygenation, in the beach chair position during shoulder surgery. Following interscalene brachial plexus anaesthesia with 20-20 ml ropivicaine 0.75%, general anaesthesia will be induced with propofol 50-200mg and maintained on sevoflurane 2-3%. Phenylephrine infusion 0.15 - 0.5 microgram/kg/min titrated to increase mean arterial pressure by 20 % versus saline infusion. Infusion is maintained whilst patient placed into beachchair position for surgery. The duration of intervention is 1 hour.
Intervention code [1] 256034 0
Treatment: Surgery
Intervention code [2] 256046 0
Treatment: Drugs
Comparator / control treatment
In control patients saline will be infused at the same rate as the phenylephrine infusion, and for the same duration. Infusions will be unmarked and contents unknown to the observer making measurements.
Control group
Placebo

Outcomes
Primary outcome [1] 257872 0
Cerebral blood flow in the beach chair position. Measurement of middle cerebral artery flow velocity via transcranial Doppler, and frontal lobe cerebral oxygenation by near infra-red spectroscopy.
Timepoint [1] 257872 0
From supine position to beach chair position
Primary outcome [2] 257898 0
Cognitive recovery. The assessment of cognitivre recovery (early and late) following surgery involves the use of a Post Operative Quality of Recovery Scale (PQRS) questionaire.
Timepoint [2] 257898 0
Patients will be tested preoperatively and following surgery at 40 min, day 1, day 3, and at 3 months.
Secondary outcome [1] 263326 0
Changes in cardiac output. Cardiac function will be assessed by transthoracic echocardiography, with measurement of left ventricular outflow tract size and blood velocity via Doppler.
Timepoint [1] 263326 0
From supine position to beach chair position
Secondary outcome [2] 263327 0
Fluid and vasopressor requirements. The extra volume of crystalloid and/or colloid, and total additional phenylephrine bolus dose and/or atropine bolus dose required to treat refractory hypotension and bradycardia.
Timepoint [2] 263327 0
From induction to completion of anaesthetic

Eligibility
Key inclusion criteria
>18 years of age
Shoulder surgery suitable for beach chair position
Able to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous cerebrovascular event
Current cardiac disease including pacemaker Cerebrovascular disease
Significant cardiac or respiratory impairment
Contraindications to interscalene block
Inadequate understanding of English
Body Mass Index (BMI) > 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)
Discussion of the study with patient prior to surgery, followed by informed, written consent.
Placement in control or intervention groups will be decided via sealed envelopes on day of procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Equal numbers of randomisation pairs using a randomisation table created by computer software,and assigned in this order to sealed envelopes by an independent person.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The person administering the treatment is unblinded and will be managing the patient's anaesthesia whilst an independent observer will take study measurements
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256534 0
University
Name [1] 256534 0
The University of Melbourne
Country [1] 256534 0
Australia
Primary sponsor type
Hospital
Name
The Avenue Hospital
Address
40 The Avenue Windsor, Victoria, 3181
Country
Australia
Secondary sponsor category [1] 255840 0
None
Name [1] 255840 0
Address [1] 255840 0
Country [1] 255840 0
Other collaborator category [1] 1123 0
University
Name [1] 1123 0
The University of Melbourne
Address [1] 1123 0
Carlton, Victoria, 3010
Country [1] 1123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258581 0
The Avenue Hospital Human Research Ethics Commitee (HREC)
Ethics committee address [1] 258581 0
40 The Avenue Windsor, Victoria, 3181
Ethics committee country [1] 258581 0
Australia
Date submitted for ethics approval [1] 258581 0
16/02/2010
Approval date [1] 258581 0
Ethics approval number [1] 258581 0

Summary
Brief summary
During shoulder surgery patients are commonly positioned into an upright sitting position for optimal access to the shoulder joint.

In some patients blood pressure may decrease and a concern of the anaesthetist is whether sufficient blood reaches the brain during such surgery. Even though this can be routinely treated with cardiac drugs, the exact effect of this treatment on the brain is unknown.

This study plans to investigate the changes in cardiac function and flow to the brain when patients are anaesthetised and placed upright. 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 a general anaesthetic.

Special monitoring of the heart and blood flow using sound waves, and brain function using reflected light waves will be used. These techniques are both non-invasive and present no harm to the patient. The study will investigate whether the administration of medication to gently increase blood pressure has an effect on hypotension and blood flow to the brain. In addition postoperative cognitive recovery will be assessed via a questionaire.

By agreeing to the study patients will give us permission to make these extra measurements during anaesthesia, in order to understand whether we are protecting the brain during surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30855 0
Address 30855 0
Country 30855 0
Phone 30855 0
Fax 30855 0
Email 30855 0
Contact person for public queries
Name 14102 0
Dr Paul Soeding
Address 14102 0
Cardiovascular therapeutics unit
level 8, medical sciences building
University of Melbourne, Carlton, Victoria, 3010
Country 14102 0
Australia
Phone 14102 0
+61383445673
Fax 14102 0
Email 14102 0
paulsoeding@bigpond.com.au
Contact person for scientific queries
Name 5030 0
Dr Paul Soeding
Address 5030 0
Cardiovascular therapeutics unit
level 8, medical sciences building
University of Melbourne, Carlton, Victoria, 3010
Country 5030 0
Australia
Phone 5030 0
+61383445673
Fax 5030 0
Email 5030 0
paulsoeding@bigpond.com.au

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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Documents added automatically
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