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Trial registered on ANZCTR


Registration number
ACTRN12621000850875
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
1/07/2021
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Sneezing under intravenous sedation during nasal local anaesthetic injection for plastic surgery procedures
Scientific title
The effect of fentanyl co-administration on sneezing during nasal local anaesthetic injection for adults undergoing plastic surgery under propofol-based intravenous sedation: Randomised-Controlled Blinded Trial
Secondary ID [1] 304295 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sneezing 322028 0
Intravenous sedation 322029 0
Condition category
Condition code
Anaesthesiology 319756 319756 0 0
Anaesthetics
Surgery 319758 319758 0 0
Other surgery
Public Health 319759 319759 0 0
Other public health
Respiratory 319760 319760 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. FENTANYL INTRAVENOUS 0.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 1)

AND

2. FENTANYL INTRAVENOUS 1.5microg/kg (ideal body weight) once + [Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL] + (Intervention group 2)

In both groups, the total dose of propofol delivered to the participant will be based on reaching the predefined depth of sedation level using the Modified Ramsay Sedation Scale of 6 to 8. Bispectral Index Monitoring is also attached as another marker to monitor the level of sedation. The depth of sedation therefore is controlled.

Adherence to this intervention is ensured by patient medical records, and recordings made by an independent observer/research assistant present during the case.
Intervention code [1] 320634 0
Treatment: Drugs
Comparator / control treatment
1. Propofol, intravenous, delivered once, in an infusion using target controlled infusion via Marsh model set initially at 3micrograms per mL. (Control)

The total dose of propofol delivered to the participant will be based on reaching the predefined depth of sedation level using the Modified Ramsay Sedation Scale of 6 to 8. Bispectral Index Monitoring is also attached as another marker to monitor the level of sedation. The depth of sedation therefore is controlled.
Control group
Active

Outcomes
Primary outcome [1] 327620 0
Incidence of inducing the sneeze reflex

An independent observer/research assistant will be present in every case to witness, assess and document the incidence of sneezing according to the requirement set out on standardised data collection sheet.
Timepoint [1] 327620 0
At time of, and shortly after nasal local anaesthetic injection to a maximum of 5 minutes.
Secondary outcome [1] 395950 0
Respiratory depression requiring airway manoeuvres

An independent observer/research assistant will be present in every case to witness, assess and document the incidence of this event according to the requirement set out on standardised data collection sheet.
Timepoint [1] 395950 0
During surgery
Secondary outcome [2] 395951 0
Haemodynamic parameters including blood pressure, and heart rate.

Each participant will be attached to standard monitoring as set out by the Guideline on sedation and/or analgesia for diagnostic and interventional medical, dental or surgical procedures by The Australian and New Zealand College of Anaesthetists. For these parameters, non-invasive blood pressure measurement and pulse rate as displayed on the anaesthesia machine monitored through pulse oximetry and electrocardiographs are used.

An independent observer/research assistant will be present in every case to witness, assess and document the parameters according to the requirement set out on standardised data collection sheet.
Timepoint [2] 395951 0
During surgery
Secondary outcome [3] 395952 0
Oxygen saturation level

Each participant will be attached to standard monitoring as set out by the Guideline on sedation and/or analgesia for diagnostic and interventional medical, dental or surgical procedures by The Australian and New Zealand College of Anaesthetists. For this parameter, pulse oximetry is used.

An independent observer/research assistant will be present in every case to witness, assess and document the parameters according to the requirement set out on standardised data collection sheet.
Timepoint [3] 395952 0
during surgery

Eligibility
Key inclusion criteria
Participants admitted to the study will be adult surgical patients aged 18 and over who require nasal injections of local anaesthetics under intravenous sedation for plastic surgical procedures on the nose
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they have known allergy to propofol or fentanyl or their refusal to participate.

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)
Randomisation will be performed by independent research assistant employed for the period of the trial. Patients will be randomised using opaque sealed envelopes with the randomisation sequence determined using computer-generated, block randomisation with variable block sizes. Patients will be assigned in a 1:1:1 ratio to either 0.5microg/kg of intravenous, 1.5microg/kg of intravenous fentanyl or no intravenous fentanyl.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised using opaque sealed envelopes with the randomisation sequence determined using computer-generated, block randomisation with variable block sizes.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be assessed for normality. Group comparisons will be performed using chi-square tests for equal proportion (or Fishers exact tests where numbers are small), analysis of variance or student t-tests for normally distributed data and Kruskal Wallis tests or Wilcoxon ranks tests otherwise with results reported as frequency (%), means (standard deviation) and medians (interquartile range) respectively. The primary outcome (proportion of patients that sneezed) will further be analysed using logistic regression with results reported as Odds ratios (95%CI). To ensure any observed finding are not due to baseline imbalance, sensitivity analysis will be performed adjusting for imbalanced baseline variables (p<0.2). All analyses will be performed using SAS version 9.4 (SAS Institute., Inc., Cary, NC) and to account for 3 pairwise group comparisons, a two sided p-value of 0.017 (0.05/3) will be used to indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/07/2021
Actual
Date of last participant enrolment
Anticipated
6/04/2022
Actual
Date of last data collection
Anticipated
6/04/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19523 0
Portland District Health - Portland
Recruitment postcode(s) [1] 34122 0
3305 - Portland

Funding & Sponsors
Funding source category [1] 308672 0
Hospital
Name [1] 308672 0
Portland District Health
Country [1] 308672 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Portland District Health
Address
Department of Anaesthesia
Portland District Health
141-151 Bentinck Street, Portland, 3305, VIC
Country
Australia
Secondary sponsor category [1] 309548 0
Hospital
Name [1] 309548 0
Portland District Health
Address [1] 309548 0
Portland District Health
141-151 Bentinck Street, Portland, 3305, VIC
Country [1] 309548 0
Australia
Secondary sponsor category [2] 309550 0
University
Name [2] 309550 0
The University of Queensland
Address [2] 309550 0
The University of Queensland
St Lucia, 4067, QLD
Country [2] 309550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308595 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 308595 0
Ethics committee country [1] 308595 0
Australia
Date submitted for ethics approval [1] 308595 0
12/06/2020
Approval date [1] 308595 0
13/04/2021
Ethics approval number [1] 308595 0
HREC/65803/VICBH-2021-258601(v4)

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

Contacts
Principal investigator
Name 111266 0
Dr Jun Parker
Address 111266 0
Portland District Health
141-151 Bentinck Street, Portland, VIC 3305
Country 111266 0
Australia
Phone 111266 0
+61431711746
Fax 111266 0
Email 111266 0
jparker.pdh@swarh.vic.gov.au
Contact person for public queries
Name 111267 0
Jun Parker
Address 111267 0
Portland District Health
141-151 Bentinck Street, Portland, VIC 3305
Country 111267 0
Australia
Phone 111267 0
+61 3 5521 0333
Fax 111267 0
Email 111267 0
jparker.pdh@swarh.vic.gov.au
Contact person for scientific queries
Name 111268 0
Jun Parker
Address 111268 0
Portland District Health
141-151 Bentinck Street, Portland, VIC 3305
Country 111268 0
Australia
Phone 111268 0
+61431711746
Fax 111268 0
Email 111268 0
jparker.pdh@swarh.vic.gov.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11745Study protocol    382052-(Uploaded-16-06-2021-14-13-15)-Study-related document.docx
11746Ethical approval    382052-(Uploaded-24-05-2021-11-41-57)-Study-related document.pdf
11747Informed consent form    382052-(Uploaded-24-05-2021-11-41-57)-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
No additional documents have been identified.