Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000675426
Ethics application status
Approved
Date submitted
26/04/2025
Date registered
25/06/2025
Date last updated
25/06/2025
Date data sharing statement initially provided
25/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathing support in breast camcer surgery: Remimazolam without muscle relaxants
Scientific title
Supraglottic ventilation in anesthesia for breast cancer surgery: Efficacy of remimazolam without muscle relaxants
Secondary ID [1] 314295 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 337235 0
Condition category
Condition code
Anaesthesiology 333645 333645 0 0
Anaesthetics
Cancer 334158 334158 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will include sixty consecutive patients undergoing elective breast cancer surgery under general anesthesia, in cases where the airway can be managed using a laryngeal mask airway (LMA).
Prior to induction, standard monitoring (non-invasive blood pressure, pulse oximetry, ECG) and additional BIS (bispectral index) monitoring will be established. A preoperative blood sample will be taken to measure neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and glucose (GUK).
In the intervention group, anesthesia will be induced with remimazolam 0.25 mg/kg IV and sufentanil 0.3 mcg/kg IV, followed by continuous infusion of remimazolam at 1–2 mg/kg/h, adjusted according to BIS values. The target BIS range will be 40–60. BIS values will be recorded every 5 minutes throughout the procedure. The time to loss of the ciliary reflex and the time until BIS drops below 60 will also be recorded.
After LMA placement, insertion conditions will be assessed using a three-point scale based on six variables, and the number of insertion attempts will be documented. If deepening of anesthesia is required, patients will receive an additional dose of either 0.5 mg/kg IV propofol or 0.1 mg/kg IV remimazolam.
After surgery, the continuous infusion of anesthetics will be stopped, and the time to spontaneous recovery—defined as BIS > 80—will be monitored every minute. A second blood sample will be collected 4 to 6 hours after the beginning of surgery to repeat the same laboratory analyses (NLR, PLR, CRP, and GUK).
Intervention code [1] 330909 0
Treatment: Drugs
Comparator / control treatment
In the control group, induction will be performed with propofol 2.5 mg/kg IV and sufentanil 0.3 mcg/kg IV, followed by a continuous infusion of propofol at 1–2 mg/kg/h, adjusted according to BIS. The target BIS range will be 40–60. BIS values will be recorded every 5 minutes throughout the procedure. The time to loss of the ciliary reflex and the time until BIS drops below 60 will also be recorded.
Control group
Active

Outcomes
Primary outcome [1] 341228 0
Difference in the graded scale for assessing conditions for LMA insertion
Timepoint [1] 341228 0
After the first attempt at LMA insertion.
Secondary outcome [1] 446828 0
Induction of anesthesia time
Timepoint [1] 446828 0
At the induction of anesthesia
Secondary outcome [2] 446829 0
Induction of anesthesia time
Timepoint [2] 446829 0
At the induction of anesthesia
Secondary outcome [3] 446830 0
Success rate of LMA insertion
Timepoint [3] 446830 0
At the induction of anesthesia
Secondary outcome [4] 446831 0
Haemodynamics
Timepoint [4] 446831 0
Before the induction of anesthesia and every 5 minutes during the procedure
Secondary outcome [5] 446832 0
Haemodynamics
Timepoint [5] 446832 0
Before the induction of anesthesia and every 5 minutes during the procedure
Secondary outcome [6] 446833 0
Haemodynamics
Timepoint [6] 446833 0
Before the induction of anesthesia and every 5 minutes during the procedure.
Secondary outcome [7] 446834 0
Drug dosage
Timepoint [7] 446834 0
During the procedure.
Secondary outcome [8] 446835 0
Time to fully awake from anesthesia
Timepoint [8] 446835 0
After the discontinuation of the drugs
Secondary outcome [9] 446836 0
Stress factors from blood
Timepoint [9] 446836 0
The three time periods are: preoperative, 4-6 hours postoperatively, and 24 hours postoperatively
Secondary outcome [10] 446837 0
Stress factors from blood
Timepoint [10] 446837 0
The three time periods are: preoperative, 4-6 hours postoperatively, and 24 hours postoperatively
Secondary outcome [11] 446838 0
Stress factors from blood
Timepoint [11] 446838 0
The three time periods are: preoperative, 4-6 hours postoperatively, and 24 hours postoperatively
Secondary outcome [12] 446839 0
Stress factors from blood
Timepoint [12] 446839 0
The three time periods are: preoperative, 4-6 hours postoperatively, and 24 hours postoperatively

Eligibility
Key inclusion criteria
Elective surgical procedure for breast cancer under general anesthesia, where airway management can be secured using a laryngeal mask, with ASA status I, II, and III. Age 18 years and over.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include age under 18 years, allergy to any of the used medications, morbid obesity (body mass index >40), active smokers, patients with psychiatric diagnoses or chronic benzodiazepine use, and patients who refuse to participate in the study.

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)
sealed opaque envelopes
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
30/03/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 27007 0
Croatia
State/province [1] 27007 0

Funding & Sponsors
Funding source category [1] 318813 0
Hospital
Name [1] 318813 0
University Hospital Center Sestre milosrdnice
Country [1] 318813 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Center Sestre milosrdnice
Address
Country
Croatia
Secondary sponsor category [1] 321259 0
Hospital
Name [1] 321259 0
University Hospital Center Sestre milosrdnice
Address [1] 321259 0
Country [1] 321259 0
Croatia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317427 0
Ethics Committee of University Hospital Center Sestre milosrdnice
Ethics committee address [1] 317427 0
Ethics committee country [1] 317427 0
Croatia
Date submitted for ethics approval [1] 317427 0
29/04/2025
Approval date [1] 317427 0
13/05/2025
Ethics approval number [1] 317427 0

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

Contacts
Principal investigator
Name 141010 0
Dr Tomislav Radocaj
Address 141010 0
Clinical hospital center Sisters of charity, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb
Country 141010 0
Croatia
Phone 141010 0
+385993787276
Fax 141010 0
Email 141010 0
[email protected]
Contact person for public queries
Name 141011 0
Tomislav Radocaj
Address 141011 0
Clinical hospital center Sisters of charity, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb
Country 141011 0
Croatia
Phone 141011 0
+385993787276
Fax 141011 0
Email 141011 0
[email protected]
Contact person for scientific queries
Name 141012 0
Tomislav Radocaj
Address 141012 0
Clinical hospital center Sisters of charity, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb
Country 141012 0
Croatia
Phone 141012 0
+385993787276
Fax 141012 0
Email 141012 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    LMA remi breast cancer.pdf


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.