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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
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Scientific title
Comparison of TCI propofol vs continuous infusion of remimazolam for drug induced sleep endoscopy (DISE) in adults: a prospective clinical study
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Secondary ID [1]
312733
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nil known
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Universal Trial Number (UTN)
U1111-1311-7813
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea
334761
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Condition category
Condition code
Anaesthesiology
331318
331318
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329255
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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time from stopping the infusion to awakening of the patient
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Assessment method [1]
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Time to achieve Bispectral index (BIS) of 80
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Timepoint [1]
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Bispectral index (BIS) of 80 after stopping the infusion
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Secondary outcome [1]
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time from starting infusion until the patient is sedated
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Assessment method [1]
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time to achieve BIS 60 or start off snoring whitch comes first
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Timepoint [1]
438483
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immediately after patient is sedated
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Secondary outcome [2]
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Haemodinamic stability, we will be assessing blood pressure and heart rate.
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Assessment method [2]
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blood pressure- measured by automatic non invasive blood pressure monitor
heart rate-masured by 3 leads continous ECG
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Timepoint [2]
438484
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during the procedure every 5 minutes
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Secondary outcome [3]
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respiratory depression- number of desaturation, this will be assessed as a composite outcome
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Assessment method [3]
438485
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pulse oximetry
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Timepoint [3]
438485
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every minute during the procedure
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Secondary outcome [4]
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additional manouvers to maintain airway patency
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Assessment method [4]
439288
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jaw thrust used or Guedel airway tube applied, noted in medical chart
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Timepoint [4]
439288
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every minute during the procedure
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Eligibility
Key inclusion criteria
patient scheduled for drug induced sleep endoscopy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/10/2024
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Actual
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Date of last participant enrolment
Anticipated
1/10/2026
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Actual
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Date of last data collection
Anticipated
1/10/2026
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Actual
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Sample size
Target
56
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26502
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Croatia
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State/province [1]
26502
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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uhc sestre milosrdnice
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Address [1]
317162
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Country [1]
317162
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Croatia
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Primary sponsor type
Hospital
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Name
UHC sestre Milosrdnice
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Address
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Country
Croatia
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Secondary sponsor category [1]
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None
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Name [1]
319429
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Address [1]
319429
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Country [1]
319429
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315910
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Ethics committee of UHC Sestre milosrdnice
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Ethics committee address [1]
315910
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kbcsm@kbcsm.hr
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Ethics committee country [1]
315910
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Croatia
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Date submitted for ethics approval [1]
315910
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28/06/2024
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Approval date [1]
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09/07/2024
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Ethics approval number [1]
315910
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251-29-11/3-24-07
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Summary
Brief summary
The aim of the study is to compare the effectiveness of TCI propofol and continuous infusion remimazolam in sedation for drug induced sleep endoscopy, with an emphasis on the required wake-up time after the procedure. Participants will be divided into two group (one recieving sedation via TCI Propofol and the other via remimazolam infusion).The following data will be recorded: informed consent for anesthesia and information on admission, informed consent for the study, demographic and clinical characteristics of the patient (age, sex, height, weight, BMI, ASA status, Mallampati score, comorbidities and previous use of CPAP machine), time from the start of the infusion to reaching BIS 60, the drug dose that was needed to achieve BIS 60/snoring , time to snoring, time from stopping the infusion until BIS 80 is achieved, number of episodes of desaturation, necessary additional maneuvers to maintain the airway patency if we used them. Hemodinamics will be measured during the whole procedure (blood pressure, heart rate and oxygen saturation) every 5 minutes. We assume that remimazolam will prove to be more efficient than propofol, meaninig faster to achieve sedation, faster wake up time and less hemodinamic instability.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Maja Koncic
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Address
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UHC Sestre Milosrdnice, Vinogradska cesta 29, 10000 Zagreb
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Country
136186
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Croatia
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Phone
136186
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+385993103052
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Fax
136186
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Email
136186
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[email protected]
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Contact person for public queries
Name
136187
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Maja Koncic
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Address
136187
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UHC Sestre Milosrdnice, Vinogradska cesta 29, 10000 Zagreb
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Country
136187
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Croatia
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Phone
136187
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+385993103052
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Fax
136187
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Email
136187
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[email protected]
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Contact person for scientific queries
Name
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Maja Koncic
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Address
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UHC Sestre Milosrdnice, Vinogradska cesta 29, 10000 Zagreb
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Country
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Croatia
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Phone
136188
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+385993103052
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Fax
136188
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Email
136188
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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