Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001302347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
29/05/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Remimazolam as an adjunct to sevoflurane anaesthesia and recovery quality in elderly surgical patients
Scientific title
Effect of remimazolam adjunct to sevoflurane anaesthesia on early postoperative recovery quality (QoR-15) in patients aged 65 years and older undergoing elective laparoscopic abdominal surgery: a randomised controlled trial
Additional trial identifiers [1] 317434 0
nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Postoperative recovery 342120 0
General anaesthesia in elderly patients 342121 0
Condition category
Condition code
Anaesthesiology 338232 338232 0 0
Anaesthetics
Mental Health 338233 338233 0 0
Studies of normal psychology, cognitive function and behaviour
Surgery 338234 338234 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Induction of anaesthesia: Propofol 1.0–1.5 mg/kg intravenously (slow titration, approximately 20 mg every 10 seconds), sufentanil 0.2–0.4 micrograms/kg intravenously, and rocuronium 0.6 mg/kg intravenously.
Maintenance of anaesthesia: Sevoflurane titrated to maintain a bispectral index (BIS) between 40 and 60 and an age-adjusted minimum alveolar concentration (MAC) considered appropriate for the procedure, together with a continuous infusion of remimazolam at 0.1 mg/kg/h.
Monitoring of neuromuscular blockade: Neuromuscular function will be monitored using train-of-four (TOF) monitoring throughout the procedure.
Reversal of neuromuscular blockade: Sugammadex will be administered according to train-of-four (TOF) monitoring results: 2 mg/kg when the TOF count is two, and 4 mg/kg in the presence of deep neuromuscular blockade.
Extubation: Tracheal extubation will be performed when the train-of-four (TOF) ratio is at least 0.9.
Eligible surgical procedures: Elective laparoscopic cholecystectomy, laparoscopic hernia repair (inguinal, umbilical, or epigastric), and diagnostic laparoscopy with an anticipated duration of anaesthesia of no more than 120 minutes.
Assessment of adherence to the intervention: Adherence to the anaesthetic protocol will be assessed through review of anaesthesia records and electronic medical records. The following variables will be recorded: administered induction drug doses, end-tidal sevoflurane concentrations, minimum alveolar concentration (MAC) values, remimazolam infusion rate, BIS values, TOF monitoring values, sugammadex dose, TOF ratio before extubation, and duration of anaesthesia. Compliance with the protocol will be evaluated by comparing documented practice with the predefined study intervention.
Intervention code [1] 334229 0
Treatment: Drugs
Description of the comparator or control
Induction of anaesthesia (identical to the intervention group): Propofol 1.0–1.5 mg/kg intravenously (slow titration, approximately 20 mg every 10 seconds), sufentanil 0.2–0.4 micrograms/kg intravenously, and rocuronium 0.6 mg/kg intravenously.
Maintenance of anaesthesia:Sevoflurane titrated to maintain a bispectral index (BIS) between 40 and 60.
Monitoring of neuromuscular blockade: Neuromuscular function will be monitored using train-of-four (TOF) monitoring throughout the procedure.
Reversal of neuromuscular blockade: Sugammadex will be administered according to train-of-four (TOF) monitoring results: 2 mg/kg when the TOF count is two, and 4 mg/kg in the presence of deep neuromuscular blockade.
Extubation: Tracheal extubation will be performed when the train-of-four (TOF) ratio is at least 0.9.
Eligible surgical procedures: Elective laparoscopic cholecystectomy, laparoscopic hernia repair (inguinal, umbilical, or epigastric), and diagnostic laparoscopy with an anticipated duration of anaesthesia of no more than 120 minutes.
Control group
Active

Outcomes
Primary outcome [1] 345598 0
Quality of early postoperative recovery
Timepoint [1] 345598 0
24 hours after surgery
Secondary outcome [1] 462332 0
hypotension
Timepoint [1] 462332 0
intraoperative
Secondary outcome [2] 462335 0
time to extubation
Timepoint [2] 462335 0
end of surgery
Secondary outcome [3] 462340 0
Perioperative inflammatory biomarkers from routine complete blood count (CBC); neutrophils and lymphocyte
Timepoint [3] 462340 0
Preoperative and 24 hours after surgery.
Secondary outcome [4] 462341 0
Intraoperative opioid consumption
Timepoint [4] 462341 0
intraoperative
Secondary outcome [5] 462342 0
Postoperative analgesic consumption
Timepoint [5] 462342 0
within 24 hours after surgery.
Secondary outcome [6] 462343 0
Postoperative nausea and vomiting (PONV) will be assessed as a composite secondary outcome, defined as the occurrence of nausea, vomiting, or both during the postoperative assessment period.
Timepoint [6] 462343 0
within 24 hours after surgery.
Secondary outcome [7] 462344 0
Perioperative inflammatory biomarkers from standard laboratory blood test
Timepoint [7] 462344 0
Preoperative and 24 hours after surgery.

Eligibility
Key inclusion criteria
Age 65 years or older
ASA physical status II–III
Elective laparoscopic abdominal surgery, specifically:
– Laparoscopic cholecystectomy
– Laparoscopic repair of inguinal, umbilical, or epigastric hernia
– Diagnostic laparoscopy
Anticipated duration of general anaesthesia of 120 minutes or less
Written informed consent obtained prior to enrolment
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Significant hepatic insufficiency
2. Significant renal insufficiency
3. Chronic therapy with benzodiazepines or antipsychotics
4. Known hypersensitivity to any study drug (propofol, remimazolam, sevoflurane, sufentanil, rocuronium, sugammadex)
5. Emergency surgical procedure
6. Psychiatric or neurological disorder precluding valid outcome assessment

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
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
15/12/2026
Actual
Date of last participant enrolment
Anticipated
15/12/2027
Actual
Date of last data collection
Anticipated
16/12/2027
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment outside Australia
Country [1] 28164 0
Croatia
State/province [1] 28164 0

Funding & Sponsors
Funding source category [1] 322010 0
Hospital
Name [1] 322010 0
Sestre Milosrdnice University Hospital Center
Country [1] 322010 0
Croatia
Primary sponsor type
Hospital
Name
Sestre Milosrdnice University Hospital Center
Address
Country
Croatia
Secondary sponsor category [1] 324887 0
Hospital
Name [1] 324887 0
Sestre Milosrdnice University Hospital Center
Address [1] 324887 0
Country [1] 324887 0
Croatia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320542 0
Ethics Committee of Sestre Milosrdnice University Hospital Center
Ethics committee address [1] 320542 0
Ethics committee country [1] 320542 0
Croatia
Date submitted for ethics approval [1] 320542 0
29/05/2026
Approval date [1] 320542 0
08/06/2026
Ethics approval number [1] 320542 0

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

Contacts
Principal investigator
Name 150810 0
Dr Tomislav Radocaj
Address 150810 0
Universitiy Hospital Center Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb, Croatia.
Country 150810 0
Croatia
Phone 150810 0
+385993787276
Fax 150810 0
Email 150810 0
[email protected]
Contact person for public queries
Name 150811 0
Tomislav Radocaj
Address 150811 0
Universitiy Hospital Center Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb, Croatia.
Country 150811 0
Croatia
Phone 150811 0
+385993787276
Fax 150811 0
Email 150811 0
[email protected]
Contact person for scientific queries
Name 150812 0
Tomislav Radocaj
Address 150812 0
Universitiy Hospital Center Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb, Croatia.
Country 150812 0
Croatia
Phone 150812 0
+385993787276
Fax 150812 0
Email 150812 0
[email protected]

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


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.