Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001234505
Ethics application status
Approved
Date submitted
10/08/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Target-Controlled Infusion (TCI) vs continuous infusion of remimazolam for drug induced sleep endoscopy (DISE): a prospective clinical study
Scientific title
Comparison of TCI propofol vs continuous infusion of remimazolam for drug induced sleep endoscopy (DISE) in adults: a prospective clinical study
Secondary ID [1] 312733 0
nil known
Universal Trial Number (UTN)
U1111-1311-7813
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 334761 0
Condition category
Condition code
Anaesthesiology 331318 331318 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients scheduled for drug induced sleep endoscopy will be divaded in 2 groups.
One will be sedated using target control infusion of propofol -1-3mcg/ml while the other group will be sedated using continous infusion of remimazolam 0,5-2 mg/kg/hour. Sedation will be administered by specialist of anesthesiology and will be monitored by observation and bispectral index monitoring.
Intervention code [1] 329255 0
Treatment: Drugs
Comparator / control treatment
Comparator/Control treatment will be group in which sedation is achieved using target control infusion-TCI propofol 1-3mcg/ml, administered by specialist of anesthesiology and will will be monitored by observation and bispectral index monitoring.
Control group
Active

Outcomes
Primary outcome [1] 339079 0
time from stopping the infusion to awakening of the patient
Timepoint [1] 339079 0
Bispectral index (BIS) of 80 after stopping the infusion
Secondary outcome [1] 438483 0
time from starting infusion until the patient is sedated
Timepoint [1] 438483 0
immediately after patient is sedated
Secondary outcome [2] 438484 0
Haemodinamic stability, we will be assessing blood pressure and heart rate.
Timepoint [2] 438484 0
during the procedure every 5 minutes
Secondary outcome [3] 438485 0
respiratory depression- number of desaturation, this will be assessed as a composite outcome
Timepoint [3] 438485 0
every minute during the procedure
Secondary outcome [4] 439288 0
additional manouvers to maintain airway patency
Timepoint [4] 439288 0
every minute during the procedure

Eligibility
Key inclusion criteria
patient scheduled for drug induced sleep endoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are allergic to eggs, milk, soy, propofol or midazolam, then patients with BMI higher than 40, pregnant women and patients with ASA status 3 and above will be excluded

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 26502 0
Croatia
State/province [1] 26502 0

Funding & Sponsors
Funding source category [1] 317162 0
Hospital
Name [1] 317162 0
uhc sestre milosrdnice
Country [1] 317162 0
Croatia
Primary sponsor type
Hospital
Name
UHC sestre Milosrdnice
Address
Country
Croatia
Secondary sponsor category [1] 319429 0
None
Name [1] 319429 0
Address [1] 319429 0
Country [1] 319429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315910 0
Ethics committee of UHC Sestre milosrdnice
Ethics committee address [1] 315910 0
Ethics committee country [1] 315910 0
Croatia
Date submitted for ethics approval [1] 315910 0
28/06/2024
Approval date [1] 315910 0
09/07/2024
Ethics approval number [1] 315910 0
251-29-11/3-24-07

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

Contacts
Principal investigator
Name 136186 0
Mrs Maja Koncic
Address 136186 0
UHC Sestre Milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 136186 0
Croatia
Phone 136186 0
+385993103052
Fax 136186 0
Email 136186 0
maja.koncic@kbcsm.hr
Contact person for public queries
Name 136187 0
Maja Koncic
Address 136187 0
UHC Sestre Milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 136187 0
Croatia
Phone 136187 0
+385993103052
Fax 136187 0
Email 136187 0
maja.koncic@kbcsm.hr
Contact person for scientific queries
Name 136188 0
Maja Koncic
Address 136188 0
UHC Sestre Milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 136188 0
Croatia
Phone 136188 0
+385993103052
Fax 136188 0
Email 136188 0
maja.koncic@kbcsm.hr

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
No additional documents have been identified.