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Trial registered on ANZCTR


Registration number
ACTRN12625000041459
Ethics application status
Approved
Date submitted
20/10/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Date results provided
20/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the Effects of Nebulised Dexmedetomidine for Premedication on Inflammatory and Oxidative Stress Response in Children Undergoing Tonsillotomy and Adenoidectomy: A Pilot Study
Scientific title
Assessment of the Effects of Nebulised Dexmedetomidine Premedication on Oxidative and Inflammatory Stress Response in Children Undergoing Tonsillotomy and Adenoidectomy: A Randomized Controlled Trial
Secondary ID [1] 313142 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 335443 0
Other mental health disorders 335699 0
Condition category
Condition code
Anaesthesiology 332003 332003 0 0
Other anaesthesiology
Mental Health 332265 332265 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Interventional group received nebulized dexmedetomidine.
Preparation of nebulized dexmedetomidine: Dexmedetomidine 200mcg/2ml dissolved in aqua for injections up to 8ml to final concentration of 20mcg in 1 ml. Every patient received 2mcg/kg of dexmedetomidine dissolved with 2.5ml of normal saline in form of inhalation in duration of 15 minutes, 30 minutes before the induction of anesthesia. Nebulized dexmedetomidine was administered by anesthesiologist.
Intervention code [1] 329750 0
Treatment: Drugs
Comparator / control treatment
Arm 2.The Control group received inhalation of saline solution during 15 minutes in the amount of 2.5 ml 30 minutes before induction of anesthesia.
Control group
Placebo

Outcomes
Primary outcome [1] 339622 0
Level of Malondialdehyde (MDA) in plasma
Timepoint [1] 339622 0
Baseline (before inhalation) and after the operation
Primary outcome [2] 339833 0
Level of nitric oxide determination (NO) in plasma
Timepoint [2] 339833 0
Baseline (before inhalation) and after operation
Primary outcome [3] 339834 0
Level of total glutathione (tGSH) in plasma
Timepoint [3] 339834 0
Baseline (before inhalation) and after operation
Secondary outcome [1] 440654 0
Sedation.
Timepoint [1] 440654 0
Ramsey score: baseline and 30 minutes after inhalation
Secondary outcome [2] 440856 0
Depth of anaesthesia.
Timepoint [2] 440856 0
preoperative: baseline and 30 minutes afer inhalatio;, intraoperative on 5 minutes; postoperative 15 minutes after extubation
Secondary outcome [3] 440857 0
hemodynamics ( heart rate, noninvasive blood pressure)
Timepoint [3] 440857 0
preoperative: baseline and 30 minutes after inhalation; intraoperative for 5 minutes; postoperative 15 minutes after extubation
Secondary outcome [4] 440858 0
monitoring of respiratory rate (respirations per minute)
Timepoint [4] 440858 0
preoperative period baseline and 30 minutes after inhalation; intraoperative for five minutes; postoperative 15 minutes after extubation
Secondary outcome [5] 440859 0
intraoperative and postoperative period: analgesic consumption
Timepoint [5] 440859 0
intraoperative for every five minutes and on the otorhinolaryngology ward every three hours over the next 12 hours.
Secondary outcome [6] 440860 0
complication
Timepoint [6] 440860 0
continuously observation of patient throughout the inhalation of drugs and intraoperative and postoperative period after extubation, until discharge home from hospital
Secondary outcome [7] 440861 0
postoperative delirium
Timepoint [7] 440861 0
after extubation
Secondary outcome [8] 440862 0
postoperative pain
Timepoint [8] 440862 0
for every three hours over the next 12 hours.
Secondary outcome [9] 441588 0
Level of total superoxide dismutase activity (tSOD) in plasma.
This is an additional primary outcome.
Timepoint [9] 441588 0
Baseline (before inhalation) and after operation
Secondary outcome [10] 441589 0
Level of catalase activity (CAT) in plasma.
This is an additional primary outcome'
Timepoint [10] 441589 0
Baseline (before inhalation) and after operation
Secondary outcome [11] 441590 0
Level of (-SH) groups determination in plasma.
This is an additional primary outcome'
Timepoint [11] 441590 0
Baseline (before inhalation) and after operation
Secondary outcome [12] 441593 0
Blood count
Timepoint [12] 441593 0
baseline (before inhalation) and after operation
Secondary outcome [13] 441594 0
levels of C reactive protein
Timepoint [13] 441594 0
baseline (before inhalation) and after operation
Secondary outcome [14] 441595 0
oxygen saturation
Timepoint [14] 441595 0
preoperative period baseline and 30 minutes after inhalation; intraoperative for five minutes; postoperative 15 minutes after extubation

Eligibility
Key inclusion criteria
In study inclusion criteria :preschool and school children ASA classification I-II group scheduled for elective tonsilectomy and adenoidectomy.
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: cardiac, pulmonary, neurological, and renal diseases, liver damage, endocrinological diseases, allergies to drugs used in the study, obesity, long-term use of antihypertensives, corticosteroids or anti-inflammatory drugs, current or recent upper airway infection and recent vaccination.

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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Results will be presented as count (%), means ± standard deviation or median (25th-75thPercentile) depending on data type and distribution. Groups are compared using parametric (t test) and nonparametric (Chi-square, Mann-Whitney U test) tests. All p values less than 0.05 will be considered significant. All data will be analyzed using SPSS 29.0 (IBM Corp. Released 2023. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.) and R 3.4.2. (R Core Team (2017). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/04/2023
Date of last participant enrolment
Anticipated
Actual
28/07/2023
Date of last data collection
Anticipated
Actual
28/07/2023
Sample size
Target
30
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 26643 0
Serbia and Montenegro
State/province [1] 26643 0

Funding & Sponsors
Funding source category [1] 317587 0
Self funded/Unfunded
Name [1] 317587 0
Country [1] 317587 0
Primary sponsor type
Individual
Name
Mother and Child Health Institute Serbia, Belgrade, Serbia - Vesna Stevanovic
Address
Country
Serbia and Montenegro
Secondary sponsor category [1] 319980 0
None
Name [1] 319980 0
Address [1] 319980 0
Country [1] 319980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316290 0
Institute for Mother and Child Health Care of Serbia, Belgrade, Serbia Ethics Committee
Ethics committee address [1] 316290 0
Ethics committee country [1] 316290 0
Serbia and Montenegro
Date submitted for ethics approval [1] 316290 0
20/01/2023
Approval date [1] 316290 0
25/01/2023
Ethics approval number [1] 316290 0
10/2023
Ethics committee name [2] 316365 0
Ethics Committee Institute for Oncology and Radiology of Serbia, Belgrade, Serbia
Ethics committee address [2] 316365 0
Ethics committee country [2] 316365 0
Serbia and Montenegro
Date submitted for ethics approval [2] 316365 0
11/09/2023
Approval date [2] 316365 0
27/10/2023
Ethics approval number [2] 316365 0
21/2023

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

Contacts
Principal investigator
Name 137414 0
A/Prof Vesna Stevanovic
Address 137414 0
Institute for Mother and Child Health Care of Serbia, Belgrade, Serbia. Radoja Dakica 6, 11070 Belgrade, Serbia
Country 137414 0
Serbia and Montenegro
Phone 137414 0
+381 11 3108129
Fax 137414 0
Email 137414 0
nadjenka9@gmail.com
Contact person for public queries
Name 137415 0
Vesna Stevanovic
Address 137415 0
Institute for Mother and Child Health Care of Serbia, Belgrade, Serbia. Radoja Dakica 6, 11070 Belgrade, Serbia
Country 137415 0
Serbia and Montenegro
Phone 137415 0
+381 11 3108129
Fax 137415 0
Email 137415 0
nadjenka9@gmail.com
Contact person for scientific queries
Name 137416 0
Vesna Stevanovic
Address 137416 0
Institute for Mother and Child Health Care of Serbia, Belgrade, Serbia. Radoja Dakica 6, 11070 Belgrade, Serbia
Country 137416 0
Serbia and Montenegro
Phone 137416 0
+381 11 3108129
Fax 137416 0
Email 137416 0
nadjenka9@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
only informed consent of each patient can be shared


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24288Ethical approval    388589-(Uploaded-20-10-2024-05-12-25)-Image (119).jpg



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.