ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000548134

Ethics application status

Approved

Date submitted

2/04/2019

Date registered

8/04/2019

Date last updated

10/06/2022

Date data sharing statement initially provided

8/04/2019

Date results provided

8/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of sevoflurane versus propofol on cerebral autoregulation during anaesthesia for robot-assisted laparoscopic prostatectomy

Scientific title

A randomized comparison of the effects of Propofol versus Sevoflurane on cerebral autoregulation when conducting general anaesthesia for robot-assisted prostate surgery.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1230-6239

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anaesthesia

cerebral autoregulation

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients undergoing robotic prostate surgery will have anaesthesia initiated by Propofol. After initiation, patients will then be randomised to have their anaesthesia maintained using the volatile anaesthetic agent, sevoflurane, or the intravenous agent, propofol.

A Bispectral Index (BIS) monitor will be used to measure the depth of anaesthesia in subjects. The target BIS score is 45 +/- 5. The dosage of Propofol or Sevoflurane will vary between subjects in order to keep the BIS constant. Propofol and Sevoflurane will be constantly administered throughout the operation.
Autoregulation will be tested at hourly intervals, starting before the initiation of the steep Trendelenburg position and every hour thereafter. Autoregulation testing will require the administration of phenylephrine. Phenylephrine will be administered in order to alter Mean Arterial Pressure (MAP) between 80-100 mmHg. This is required in order to test cerebral autoregulation. Cerebral autoregulation will be tested using a TransCranial Doppler (TCD) machine. The TCD will gather blood flow velocity data from the middle cerebral artery, this will be combined with data on MAP to calculate the auto regulation index (ARI).
The intraoperative opioid will be remifentanil, administered by a target-controlled infusion with a targeted effect-site concentration of 2 mcg/mL - 4 mcg/mL.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Inhalational Sevoflurane

Control group

Active

Outcomes

Primary outcome [1]

Cerebral autoregulation will be assessed using a TransCranial Doppler (TCD). This will measure blood flow velocity in the Middle Cerebral Artery (MCA) relative to alterations in Mean Arterial Pressure (MAP). An Autoregulation Index (ARI) will be calculated and cerebral autoregulation will be said to be intact if ARI greater than 0.4 and will be said to not be intact if ARI is equal to or less than 0.4.

Timepoint [1]

The last ARI calculated whilst in the Steep Trendelenburg position before returning to the supine position will be used as the primary timepoint to determine whether cerebral autoregulation has been left intact (ARI great than 0.4) or not (ARI less than or equal to 0.4).

Secondary outcome [1]

Cerebral autoregulation was assessed at other stages during RALP, including before the initation of the steep Trendelenburg position. This will be assessed via measurement of blood flow velocity in the Middle Cerebral Artery (MCA) relative to alterations in Mean Arterial Pressure (MAP). From this, an Autoregulation Index (ARI) will be calculated and cerebral autoregulation will be said to be intact if ARI greater than 0.4 and will be said to not be intact if ARI is equal to or less than 0.4.

Timepoint [1]

Before the imitation of the steep Trendelenburg position, and hourly after steep Trendelenburg positioning (excluding final test of autoregulation)

Eligibility

Key inclusion criteria

Robotic prostatectomy

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

History of cerebral vascular disease
Intracranial pathology
Allergy to Propofol.
Contraindication to Sevoflurane, including malignant hyperthermia or history of severe postoperative nausea and vomiting.

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)

The induction of anaesthesia will be carried out using Propofol, after which, numbered opaque envelopes containing a random sequence will be opened and used to allocate the anaesthetic agent used to maintain anaesthesia.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permutated block randomisation was used to randomise patients

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other design features

The patient will be blind to group allocation.
The treating anaesthetist and investigator will be aware of the anaesthetic agent during data collection.
Investigators will be blind to the agent at the time of data analysis.

Phase

Phase 4

Type of endpoint/s

Pharmacodynamics

Statistical methods / analysis

The Fisher’s exact test was used to compare the proportion of patients in the final test of cerebral autoregulation who had their autoregulation impaired between the propofol and sevoflurane groups

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

24/05/2019

Actual

24/05/2019

Date of last participant enrolment

Anticipated

1/03/2020

Actual

9/10/2020

Date of last data collection

Anticipated

8/03/2020

Actual

9/10/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

The Chris O’Brien Lifehouse - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

50 Missenden Rd, Camperdown NSW 2050, Australia

Country [1]

Australia

Primary sponsor type

Government body

Name

Sydney Local Health District

Address

575 Canterbury Rd, Campsie NSW 2194

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee (RPAH Zone)

Ethics committee address [1]

Level 11, KGV Building Missenden Road 
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/03/2019

Approval date [1]

10/05/2019

Ethics approval number [1]

Summary

Brief summary

Currently there is no standard anesthetic agent recommended for robotic pelvic and abdominal surgery. Anaesthetic agents have variable effects on the cerebral vasculature and it has been hypothesized that some may be more suitable for robotic pelvic and abdominal surgery than others. For instance, Sevoflurane, a volatile anesthetic agent, increases cerebral vasodilation and hence decreases vascular resistance. This may impair cerebral autoregulation. Propofol, an intravenous agent, has not been shown to affect cerebral vasodilation.
 A feature of robotic surgery is the requirement for carbon dioxide pneumoperitoneum in conjunction with steep head-down positioning. We hypothesise that the cerebrovasodilatory effects of carbon dioxide combined with the potential for oedema from head-down positioning could render the brain particularly susceptible to the vasodilatory effects of volatile anaesthetics, including sevoflurane.
Cerebral oedema is a recognised, although rare, complication of robotic prostate surgery. These are long procedures with the patient in a steep head-down position. Previous studies have shown alterations in cerebral blood flow towards the end of surgery. Therefore, the primary outcome of this study will be the last cerebral autoregulation recording at the end of surgery, with a comparison between patients with their anaesthesia maintained with propofol or sevoflurane

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tim McCulloch

Address

Sydney Local Health District, Post Office Box M30 Missenden Road NSW 2050

Country

Australia

Phone

+61 2 9515 6111

Fax

tim.mcculloch@sydney.edu.au

Contact person for public queries

Name

Tomas Robertson

Address

Sydney Local Health District, Post Office Box M30 Missenden Road Camperdown NSW 2050

Country

Australia

Phone

+61 448162684

Fax

trob7144@uni.sydney.edu.au

Contact person for scientific queries

Name

Tomas Robertson

Address

Sydney Local Health District, Post Office Box M30 Missenden Road NSW 2050

Country

Australia

Phone

+61 448162684

Fax

trob7144@uni.sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Data will be available which does not allow identification of individuals. This may include recordings of cerebral autoregulation, data collection forms and other non identifiable data.

When will data be available (start and end dates)?

Data will be available immediately after publication and available up to 5 years post publication

Available to whom?

Availability will be available on a case by case basis based on approval from the Sydney Local Health District.

Available for what types of analyses?

For any research purpose

How or where can data be obtained?

Access subject to approval via the Principal Investigator

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1750	Study protocol					377268-(Uploaded-17-11-2021-22-07-33)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of sevoflurane versus propofol on cerebral autoregulation during anaesthesia for robot-assisted laparoscopic prostatectomy.	2022	https://dx.doi.org/10.1177/0310057X211061158

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically