Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000916246
Ethics application status
Approved
Date submitted
28/05/2018
Date registered
31/05/2018
Date last updated
10/09/2020
Date data sharing statement initially provided
28/03/2019
Date results information initially provided
10/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does general anaesthesia with xenon gas improve protection of the brain when compared to general anaesthesia with a standard anaesthetic agent?
Scientific title
Comparison of the effects of xenon and sevoflurane anaesthesia on neurofilament light and tau protein in patients undergoing lithotripsy: a randomised trial
Secondary ID [1] 294981 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurotoxicity 307990 0
Lithotripsy 307991 0
General anaesthesia 307992 0
Condition category
Condition code
Neurological 307025 307025 0 0
Other neurological disorders
Anaesthesiology 307129 307129 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General anaesthesia with xenon gas.

Xenon gas will be used as the sole hypnotic agent to provide general anaesthesia for participants undergoing lithotripsy. It will be administered by the inhalational route at an inspired fraction of 60% for the duration of the anaesthetic (about 45minutes) by the anaesthetist. It's use will be in conjunction with an opiod infusion (remifentanil) and other standard anaesthetic care.
Intervention code [1] 301310 0
Treatment: Drugs
Intervention code [2] 301311 0
Prevention
Comparator / control treatment
General anaesthesia with sevoflurane.

Sevoflurane gas will be used as the sole hypnotic agent to provide general anaesthesia for participants undergoing lithotripsy. It will be administered by the inhalational route at an inspired fraction of 2% for the duration of the anaesthetic (about 45minutes). It's use will be in conjunction with an opiod infusion (remifentanil) and other standard anaesthetic care.
Control group
Active

Outcomes
Primary outcome [1] 306003 0
Change in tau protein measured by plasma assay of blood
Timepoint [1] 306003 0
1 hour, 6 hours (primary timepoint), 24 hours and 72 hours post induction of anaesthesia.
Primary outcome [2] 306004 0
Change in neurofilament light measured by plasma assay of blood
Timepoint [2] 306004 0
1 hour, 6 hours, 24 hours (primary timepoint) and 72 hours post induction of anaesthesia.
Secondary outcome [1] 347282 0
Changes in biomarkers associated with inflammation measured by plasma assay of blood
Timepoint [1] 347282 0
1 hour, 6 hours, 24 hours, 72 hours post induction of anaesthesia
Secondary outcome [2] 347283 0
Incidence of post-operative nausea measured by study specific questionnaire
Timepoint [2] 347283 0
On discharge from post anaesthetic care unit
Secondary outcome [3] 347512 0
Incidence of vomiting measured by study specific questionnaire
Timepoint [3] 347512 0
On discharge from post anaesthetic care unit
Secondary outcome [4] 386802 0
Secondary outcome 4. Raw and processed EEG values at baseline, maintenance and emergence. Processed EEG values - bispectral index and cortical state. Raw EEG - total and relative power in frequency bands.
Timepoint [4] 386802 0
Intraoperative

Eligibility
Key inclusion criteria
Patients' undergoing lithotripsy at St. Vincent's Hospital, Melbourne.
Patients' living within 30minutes travel time of St. Vincent's Hospital.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
High risk of PONV (Apfel score 3 or greater)
Severe respiratory disease (unable to tolerate inspired oxygen fraction less than 35%)
Contraindication to airway management with laryngeal mask airway
Contraindication to anaesthesia with a volatile agent
Pre-existing neurodegenerative condition

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 opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random permutation block sequence
Masking / blinding
Blinded (masking 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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Evered et al. found that the mean percentage increase in tau protein was 257% in patients’ aged over 60y undergoing anaesthesia and surgery. We therefore based our power calculation on detecting a 30% reduction in the mean percentage increase of tau compared to baseline for subjects in the xenon group when compared to the sevoflurane group. Assuming a power of 80% and an alpha=0.05, we would require 18 subjects in total (9 in each group) to detect a reduction of 30% in the magnitude of rise of tau protein between the groups. Allowing for a loss to follow up (all cause) of 25% we plan to recruit 24 subjects.

All statistical analysis will be performed using STATA, version 15 (StataCorp). Independent t tests will be used for group comparisons of continuous variables. Linear correlation of continuous variables will be tested using the Pearson correlation coefficient. The chi squared or Fisher exact test will be used for dichotomous data. All hypothesis will be two-tailed and a P value of less than 0.05 used to indicate significance. Generalised linear models will be used for multivariate analysis.

Evered, L., et al., Association of Changes in Plasma Neurofilament Light and Tau Levels With Anesthesia and Surgery: Results From the CAPACITY and ARCADIAN Studies. JAMA Neurol, 2018.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2018
Actual
2/03/2019
Date of last participant enrolment
Anticipated
15/07/2019
Actual
31/10/2019
Date of last data collection
Anticipated
15/10/2019
Actual
31/10/2019
Sample size
Target
18
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22780 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 299570 0
Charities/Societies/Foundations
Name [1] 299570 0
Australia New Zealand College of Anaesthetists
Country [1] 299570 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Melbourne
Address
St. Vincent's Hospital
41 Victoria Parade
Fitzroy 3065
Country
Australia
Secondary sponsor category [1] 298885 0
None
Name [1] 298885 0
Address [1] 298885 0
Country [1] 298885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300469 0
St. Vincent's Hospital Melbourne Human Research Ethics Committee D
Ethics committee address [1] 300469 0
St. Vincent's Hospital
41 Victoria Parade
Fitzroy
Victoria 3065
Ethics committee country [1] 300469 0
Australia
Date submitted for ethics approval [1] 300469 0
01/06/2018
Approval date [1] 300469 0
20/07/2018
Ethics approval number [1] 300469 0

Summary
Brief summary
In this research project we will be comparing anaesthesia with xenon to anaesthesia with our usual anaesthetic agent, sevoflurane. Xenon has been used as an anaesthetic agent for many years but it’s use is limited because it is so expensive. In order to justify its use there needs to be good evidence that it has a significant benefit.

One area in which xenon appears to have benefit is in protecting the brain during anaesthesia and surgery. There is growing evidence that having an anaesthetic and surgery can cause some problems with how the brain functions. This is of particular concern in infants and older people. This study is considering if there is evidence that xenon may be more protective of the brain than the usual anaesthetic.

For the study, patients having a minor surgical procedure will have anaesthetic with either xenon or sevoflurane. We will take blood tests from both sets of patients. The blood tests will look for evidence of any harm to the brain cells of the patients to identify if one anaesthetic is better than the other.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83758 0
Dr Steven McGuigan
Address 83758 0
Department of Anaesthesia
St. Vincent's Hospital
41 Victoria Parade
Fitzroy 3065
Victoria
Country 83758 0
Australia
Phone 83758 0
+61392314253
Fax 83758 0
Email 83758 0
stevenmcguigan5@gmail.com
Contact person for public queries
Name 83759 0
Steven McGuigan
Address 83759 0
Department of Anaesthesia
St. Vincent's Hospital
41 Victoria Parade
Fitzroy 3065
Victoria
Country 83759 0
Australia
Phone 83759 0
+61392314253
Fax 83759 0
Email 83759 0
stevenmcguigan5@gmail.com
Contact person for scientific queries
Name 83760 0
Steven McGuigan
Address 83760 0
Department of Anaesthesia
St. Vincent's Hospital
41 Victoria Parade
Fitzroy 3065
Victoria
Country 83760 0
Australia
Phone 83760 0
+61392314253
Fax 83760 0
Email 83760 0
stevenmcguigan5@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
EmbaseComparing the effect of xenon and sevoflurane anesthesia on postoperative neural injury biomarkers: A randomized controlled trial.2022https://dx.doi.org/10.4103/2045-9912.324591
EmbasePerformance of the bispectral index and electroencephalograph derived parameters of anesthetic depth during emergence from xenon and sevoflurane anesthesia.2023https://dx.doi.org/10.1007/s10877-022-00860-y
N.B. These documents automatically identified may not have been verified by the study sponsor.