Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000754741
Ethics application status
Approved
Date submitted
15/11/2021
Date registered
26/05/2022
Date last updated
23/04/2024
Date data sharing statement initially provided
26/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ConsCIOUS-3: Will noradrenergic suppression reduce connected consciousness after intubation? A randomised, placebo controlled trial.
Scientific title
ConsCIOUS-3: Will noradrenergic suppression reduce connected consciousness after intubation?
Secondary ID [1] 305737 0
None
Universal Trial Number (UTN)
Trial acronym
ConsCIOUS-3
Linked study record
The following studies were performed in the United States and are registered on clinical trials.gov.
ConsCIOUS: NCT02248623
ConsCIOUS2: NCT03503357

ConsCIOUS 3 is a follow up to these studies to further explore awareness during anaesthesia using the isolated forearm technique with the use of dexmedetomidine. The previous studies focused on anasesthetic awareness using the isolated forearm technique during general anaesthetisia. ConsCIOUS 3 mimics the previous studies data sets.

Health condition
Health condition(s) or problem(s) studied:
Intubation for General Anaesthesia 324229 0
Condition category
Condition code
Anaesthesiology 321713 321713 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexmedetomidine 0.5mg/kg will be given intravenously (IV) over 5 minutes prior to/during intubation during a general anaesthetic.
This will be administered by the treating anaestheist and will be monitored by the principal investigator Professor Robert Sanders. Anaesthetic doctors will be trained on study protocol prior to comencement of the trial and will record the drug administration in the anaesthetic chart as dexmedetomidine/placebo. If there are any errors in administration or dose this will be reported to Professor Robert Sanders and the Research Coordinator and documented/reported as required by the local HREC.
Intervention code [1] 322134 0
Treatment: Drugs
Comparator / control treatment
Saline 0.9% intravenously at the same rate calculated for the intervention
Control group
Placebo

Outcomes
Primary outcome [1] 329473 0
To determine depth of anaesthesia assessed by the bispectral index (BIS).
Timepoint [1] 329473 0
The BIS value will be recorded at the following points: Pre-dexmedetomidine baseline, Post-dexmedetomidine peak BIS at 1, 3 and 5 minutes, BIS prior to commencement of propofol TCI, BIS following syringe drop, BIS prior to intubation and Peak BIS post-induction between 1-5. EEG recordings and 1-minutely BIS values will be captured and stored on an USB or printed on paper format for analysis.
Secondary outcome [1] 402732 0
To determine the affects of dexmedetomidine on depth of anaesthesia using isolated forearm technique responsiveness after intubation.

This will be done during the procedure through integrated functional testing (IFT) - a series of commands, responses via hand squeezes with the tourniquet inflated.
Timepoint [1] 402732 0
IFT will occur pre-intubation and post-intubation.
Secondary outcome [2] 402733 0
To determine the safety of adjunct dexmedetomidine for intubation.

This will be monitored by the anaesthetists and any adverse or serious adverse events will be reported and documented as per policy and in line with local human ethics governance office guidelines.
Timepoint [2] 402733 0
Duration of general anaesthetic/post-operative safety and reporting time 24-hours post-operatively.
Secondary outcome [3] 402734 0
BIS awareness/arousal

The post-study questionnaire has been created specifically for this study as a post-operative follow up.
Timepoint [3] 402734 0
BIS readings will be recorded at the following points: Pre-dexmedetomidine baseline Post-dexmedetomidine at 1, 3 and 5 minutes (pre-intubation), at various set points during induction and Post-intubation at 1,2 and 5 minutes A post-procedure questionnaire in recovery (15 min and 60 min) and 24 hours post-operation will be administered to assess awareness/arousal during case. IFT will be administered during the procedure as outlined in the protocol. Commands/questions will be administered and the patient will be asked to squeeze the anaesthetists hand while the participant forearm is isolated by a tourniquet to assess patient arousal/awareness after intubation.
Secondary outcome [4] 403054 0
Instance/Severity of Post-operative delirium - results will be considered together with composite outcome
Timepoint [4] 403054 0
The following assessments/rating scales will be administered in the recovery room at 15 minutes and 60 minutes post-operation:
Richmond Agitation and Sedation Scale (RASS)
Confusion Assessment Method-ICU (CAM-ICU)
Nursing Delirium Screening Scale (NuDesc)

Eligibility
Key inclusion criteria
Adults, 18 -40 years old requiring intubation for general anaesthesia
American Society of Anaesthesiologists status (ASA) 1, 2 or 3
Able and willing to provide informed consent, participate and comply with study requirements
Support of treating surgical team for participant invovlement
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons who are lactating or pregnant
Persons with a history of allergy to dexmedetomidine
Persons with history of heart block
Persons with a history of psychological illness or other conditions with may interfere with their ability to understand the study requirements
Persons with cognitive impairment that is likely to interfere with the evaluation of participant's safety and of the study outcome

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)
Central randomisation by computer program (RedCAP)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation program created by RedCap program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on , 50 subjects provides 90% power (p<0.05) to show a difference of 10 points in the
BIS. We include 2 extra patients for loss to follow up. Total sample size is 52
participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2022
Actual
26/05/2022
Date of last participant enrolment
Anticipated
15/05/2024
Actual
29/02/2024
Date of last data collection
Anticipated
22/05/2024
Actual
7/03/2024
Sample size
Target
52
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21060 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 35907 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310094 0
Hospital
Name [1] 310094 0
Royal Prince Alfred Hospital
Country [1] 310094 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
Department of Anaesthetics
50 Missenden Road
Level 4, BLDG 89
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311169 0
None
Name [1] 311169 0
Address [1] 311169 0
Country [1] 311169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309785 0
Sydney Local Health District Human Research Ethics Committee (RPAH Zone)
Ethics committee address [1] 309785 0
Ethics committee country [1] 309785 0
Australia
Date submitted for ethics approval [1] 309785 0
03/11/2021
Approval date [1] 309785 0
05/05/2022
Ethics approval number [1] 309785 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115378 0
Prof Robert Sanders
Address 115378 0
Royal Prince Alfred Hospital
Department of Anaesthetics
50 Missenden Road
Level 4, BLDG 89
Camperdown NSW 2050
Country 115378 0
Australia
Phone 115378 0
+61 02 9515 7460
Fax 115378 0
Email 115378 0
[email protected]
Contact person for public queries
Name 115379 0
Kaitlin Kramer
Address 115379 0
Royal Prince Alfred Hospital
Department of Anaesthetics
50 Missenden Road
Level 4, BLDG 89
Camperdown NSW 2050
Country 115379 0
Australia
Phone 115379 0
+61 02 9515 8789
Fax 115379 0
Email 115379 0
[email protected]
Contact person for scientific queries
Name 115380 0
Robert Sanders
Address 115380 0
Royal Prince Alfred Hospital
Department of Anaesthetics
50 Missenden Road
Level 4, BLDG 89
Camperdown NSW 2050
Country 115380 0
Australia
Phone 115380 0
+61 02 9515 7460
Fax 115380 0
Email 115380 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14004Study protocol    383080-(Uploaded-15-11-2021-21-22-53)-Study-related document.pdf
14005Informed consent form    383080-(Uploaded-08-11-2021-20-56-28)-Study-related document.pdf



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.