Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000133639
Ethics application status
Approved
Date submitted
5/12/2022
Date registered
8/02/2023
Date last updated
8/02/2023
Date data sharing statement initially provided
8/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous infusion of remimazolam for intraoperative sedation as a safe and effective option: a prospective clinical study.
Scientific title
Continuous infusion of remimazolam for intraoperative sedation as a safe and effective option: a prospective clinical study.
Secondary ID [1] 308531 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural or intraoperative sedation. 328363 0
Condition category
Condition code
Anaesthesiology 325402 325402 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: remimazolam
For patients undergoing elective procedural sedation or sedation with regional anaesthesia. Anticipated duration of the procedure is up to one hour.
Bispectral Index (BIS) monitoring using sensors which are placed on the forehead of participants is used to measure the participant's level of consciousness and with that to monitor the depth of anaesthesia.
The examiner will use Modified Observer's Alertness/Sedation scale (MOAA/S) and Richmond Agitation-Sedation Scale (RASS) values to measure the agitation or sedation level of a participants.
The examiner will measure MOAA/S and RASS values at the beginning of the procedure.
Remimazolam will be started with the loading dose of 5mg intravenously over a 1-minute time period. After the loading dose, the continuous intravenous infusion of remimazolam will start, which will be titrated to maintain the target Bispectral Index (BIS) values of 60-80 during procedure, which indicates an adequate depth of sedation.
During the entire procedure, BIS, MOAA/S and RASS values will be measured and recorded at 5-minute intervals, and depending on the obtained values, the remimazolam infusion rate will be corrected. At the end of the procedure, after stopping the administration of the drug, the time required from the end of the infusion to the complete recovery of consciousness will be measured.
Intervention code [1] 324974 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333258 0
Primary outcome is to determine the necessary range of continuous dose of remimazolam (mg/kg/h) for procedural sedation or sedation with regional anaesthesia. Sedation will be determined by evaluation of BIS, MOAA/S and RASS scores during procedure. All measurements and the dose of remimazolam will be assessed together as a composite primary outcome.
Timepoint [1] 333258 0
The primary outcome measurements will be assessed every 5 minutes from the start of sedation till complete recovery of consciousness.
Secondary outcome [1] 416382 0
Side effects registered during continuous infusion of remimazolam will be assessed by standard monitoring. Hypotension will be assessed using sphygmomanometer, bradycardia will be assessed with ECG monitoring and drop in saturation will be assessed using pulse oximeter.
Timepoint [1] 416382 0
Blood pressure measurements will be assessed every 5 minutes from the start of sedation till complete recovery of consciousness. Heart rate and saturation measurements will be assessed continuously from the start of sedation till complete recovery of consciousness.

Eligibility
Key inclusion criteria
Adult patients between 18 and 80 years of age, ASA class I, II and III, scheduled for elective procedural sedation or sedation with regional anaesthesia.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are age under 18 or over 80, allergy to any of the drugs used, body mass index (BMI) under 18 or over 30, patients with psychiatric diagnoses, and patient refusal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis
50 patients will be included in the study. The number of patients is determined by the availability and price of remimazolam. The dose required to achieve and maintain an adequate level of sedation will be analyzed for each patient. Demographic and clinical data will be recorded on a standardized form. Recorded demographic data will be: age, sex, height and weight. Recorded clinical data will be: ASA status, heart rate, mean arterial pressure, oxygen saturation, BIS score, MOAA/S and RASS scale. The rate of infusion of Remimazolam will be recorded.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2023
Actual
Date of last participant enrolment
Anticipated
24/03/2023
Actual
Date of last data collection
Anticipated
24/03/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25166 0
Croatia
State/province [1] 25166 0
City of Zagreb

Funding & Sponsors
Funding source category [1] 312776 0
Hospital
Name [1] 312776 0
University Hospital Center Sestre milosrdnice
Country [1] 312776 0
Croatia
Primary sponsor type
Individual
Name
Antonia Kustura, MD
Address
Division of Anesthesiology, Intensive Care and Pain Medicine
Sestre milosrdnice University Hospital Center
Vinogradska c. 29
10 000 Zagreb
Croatia
Country
Croatia
Secondary sponsor category [1] 314408 0
None
Name [1] 314408 0
Address [1] 314408 0
Country [1] 314408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312069 0
Eticko povjerenstvo Klinickog bolnickog centra Sestre milosrdnice (Ethics Committee of University Hospital Center Sestre milosrdnice)
Ethics committee address [1] 312069 0
Vinogradska cesta 29
10 000 Zagreb
Ethics committee country [1] 312069 0
Croatia
Date submitted for ethics approval [1] 312069 0
29/11/2022
Approval date [1] 312069 0
08/12/2022
Ethics approval number [1] 312069 0
003-06/22-03/034

Summary
Brief summary
The purpose of the research is to determine the necessary range of continuous doses of remimazole for procedural sedation or sedation with regional anesthesia as an alternative to other, less hemodynamically and respiratory safe drugs that are currently used, propofol and midazolam.
Research hypothesis: A continuous dose of remimazolam adjusted for the body weight and height of the patient is a sufficient and hemodynamically and respiratory safe alternative to currently used drugs in doses comparable to bolus doses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123354 0
Dr Antonia Kustura
Address 123354 0
Division of Anesthesiology, Intensive Care and Pain Medicine
Sestre milosrdnice University Hospital Center
Vinogradska c. 29
10 000 Zagreb
Croatia
Country 123354 0
Croatia
Phone 123354 0
+385 1 37 87 428
Fax 123354 0
Email 123354 0
[email protected]
Contact person for public queries
Name 123355 0
Dr Antonia Kustura
Address 123355 0
Division of Anesthesiology, Intensive Care and Pain Medicine
Sestre milosrdnice University Hospital Center
Vinogradska c. 29
10 000 Zagreb
Croatia
Country 123355 0
Croatia
Phone 123355 0
+385 1 37 87 428
Fax 123355 0
Email 123355 0
[email protected]
Contact person for scientific queries
Name 123356 0
Dr Antonia Kustura
Address 123356 0
Division of Anesthesiology, Intensive Care and Pain Medicine
Sestre milosrdnice University Hospital Center
Vinogradska c. 29
10 000 Zagreb
Croatia
Country 123356 0
Croatia
Phone 123356 0
+385 1 37 87 428
Fax 123356 0
Email 123356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Available only to researchers who provide a methodologically sound and valid proposal.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal, IPD meta-analyse and similar requests.
How or where can data be obtained?
The data can be obtained by contacting Principal Investigator ([email protected]) with approval of Ethics Committee.


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.