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Trial registered on ANZCTR


Registration number
ACTRN12624001124527
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the safety and effectiveness of remimazolam and propofol for general anesthesia.
Scientific title
Comparing the safety and effectiveness of remimazolam and propofol for general anesthesia in patients subject to surgery.
Secondary ID [1] 312570 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General anesthesia 334477 0
Condition category
Condition code
Anaesthesiology 331102 331102 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 60 participants will be randomly assigned to either the trial group (receiving remimazolam) or the control group (receiving propofol), with 30 participants in each group. All participants will undergo non-emergent endocholecystectomy surgery and are classified as Class 2 or 3 according to the American Society of Anesthesiologists Classification (ASA). Endocholecystectomy is a laparoscopic surgery to remove the gallbladder. It is performed by a specialist surgeon and typically takes up to 2 hours. Both remimazolam and propofol can be equally administered for total intravenous anesthesia (TIVA) at the discretion of the anesthesiologist. Random allocation to the trial or control group will be done using a random number generator. Anesthesia will be administered by an experienced anesthesiologist with over 10 years of practice in the field.
No premedication will be given to any of the participants. Both groups will undergo the same procedure with the same strategies. Standard anesthesia monitoring (non-invasive blood pressure (NBP), pulse oximetry (SpO2), continuous III-lead ECG monitoring) will be utilized, along with additional monitoring for anesthesia depth (Bispectral Index (BIS), Patient State Index (PSI)) and neuromuscular relaxation (Train of Four (TOF)). Demographic and clinical data will be recorded on a predefined form, including age, sex, height, weight, ASA classification, BIS and PSI values, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). MOAA/S (Modified Observer's Alertness/Sedation Scale), RASS (Richmond Agitation Sedation Scale), Aldrete score, and QoR-40 (Quality of Recovery 40) Questionnaire will also be noted.
BIS, PSI, SBP, DBP, HR, MOAA/S, and RASS measurements will be recorded and noted every 5 minutes during the procedure. The Aldrete score will be recorded 1 hour post-procedure, and the QoR-40 will be assessed 24 hours after the procedure. Additionally, the total amount of drugs administered, duration of surgery, time to induction and recovery from anesthesia, and any adverse effects (hypotension or bradycardia), along with any treatment drugs administered (e.g., ephedrine, norepinephrine, atropine), will be documented.
In the trial group, anesthesia induction will be achieved with an intravenous (IV) bolus of 0.25 mg/kg remimazolam, 0.5 mcg/kg/min remifentanil, and 0.6 mg/kg rocuronium. Anesthesia will be adjusted to maintain BIS values between 40-60 which should correlate with PSI values between 25-50, indicating deep anesthesia. Remifentanil will be administered based on the patient's analgesia needs, which are assessed through hemodynamic changes, pupil responses, and sweating
Intervention code [1] 329272 0
Treatment: Drugs
Comparator / control treatment
In the control group, induction of anesthesia will be performed with propofol 2mg/kg bolus IV (intravenous) and again with remifentanyl 0,5 mcg/kg/min IV and rocuronium 0.6 mg/kg IV. Anesthesia will be continued and adjusted in order to maintain BIS values 40-60 and PSI 25-50, therefore, defined as deep anesthesia. Remifentanyl will be continued based on analgesia needs (hemodynamic changes, pupil changes and sweating).
Control group
Active

Outcomes
Primary outcome [1] 338869 0
Anesthesia depth determined by BIS score
Timepoint [1] 338869 0
BIS values will be assessed for every 5 minutes during the procedure until the values reach awake state (BIS >80).
Primary outcome [2] 339213 0
Anesthesia depth determined by PSI score
Timepoint [2] 339213 0
PSI values will be assessed for every 5 minutes during the procedure until the values reach awake state (PSI>50)
Secondary outcome [1] 438539 0
Haemodynamics
Timepoint [1] 438539 0
Before the induction of anesthesia and every 5 minutes during the procedure
Secondary outcome [2] 438540 0
Haemodynamics
Timepoint [2] 438540 0
Before the induction of anesthesia and every 5 minutes during the procedure
Secondary outcome [3] 438541 0
Haemodynamics
Timepoint [3] 438541 0
Before the induction of anesthesia and every 5 minutes during the procedure.
Secondary outcome [4] 438542 0
Depth of sedation.
Timepoint [4] 438542 0
Before the induction of anesthesia and every 5 minutes during the procedure.
Secondary outcome [5] 438543 0
Recovery of anesthesia
Timepoint [5] 438543 0
One hour after the procedure is done.
Secondary outcome [6] 438544 0
Quality of recovery after surgery and anesthesia
Timepoint [6] 438544 0
24 hours after the procedure.
Secondary outcome [7] 438545 0
Induction of anesthesia time
Timepoint [7] 438545 0
At the induction of anesthesia
Secondary outcome [8] 438546 0
Time to fully awake from anesthesia
Timepoint [8] 438546 0
After the discontinuation of the drugs.
Secondary outcome [9] 438547 0
Drug dosage
Timepoint [9] 438547 0
During the procedure.
Secondary outcome [10] 439098 0
Time to fully awake from anesthesia
Timepoint [10] 439098 0
After the discontinuation of the drugs.
Secondary outcome [11] 439099 0
Induction of anesthesia time
Timepoint [11] 439099 0
At the induction of anesthesia

Eligibility
Key inclusion criteria
ASA II and III status. Age 18 years and over, Elective endocholecystectomia surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years, allergy to any of the used medications, pregnant women, emergency surgeries, morbid obesity (body mass index, BMI >40 kg/m²), and patients with psychiatric diagnoses and chronic use of benzodiazepines.

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
30/09/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26441 0
Croatia
State/province [1] 26441 0

Funding & Sponsors
Funding source category [1] 317000 0
Hospital
Name [1] 317000 0
University Hospital Center Sestre milosrdnice
Country [1] 317000 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Center Sestre milosrdnice
Address
Country
Croatia
Secondary sponsor category [1] 319246 0
Hospital
Name [1] 319246 0
University Hospital Center Sestre milosrdnice
Address [1] 319246 0
Country [1] 319246 0
Croatia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315758 0
Ethics Committee of University Hospital Center Sestre milosrdnice
Ethics committee address [1] 315758 0
University Hospital Center Sestre milosrdnice, Vinogradsa c. 29, 10000 Zagreb, Croatia
Ethics committee country [1] 315758 0
Croatia
Date submitted for ethics approval [1] 315758 0
01/07/2024
Approval date [1] 315758 0
09/07/2024
Ethics approval number [1] 315758 0

Summary
Brief summary
A new hypnotic agent, remimazolam, has recently been approved for general anesthesia. This study will involve 60 participants who will be administered either propofol or remimazolam, with both standard and additional patient monitoring. The aim is to identify any differences between the two agents and to evaluate the effectiveness of enhanced monitoring on patient awareness during general anesthesia. The study also aims to assess whether remimazolam is more effective than propofol in achieving general anesthesia, particularly in terms of hemodynamic stability and patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135702 0
Dr Matej Cindric
Address 135702 0
Clinical hospital center Sestre milosrdnice, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb
Country 135702 0
Croatia
Phone 135702 0
+385 1 3787 111
Fax 135702 0
Email 135702 0
[email protected]
Contact person for public queries
Name 135703 0
Matej Cindric
Address 135703 0
Clinical hospital center Sestre milosrdnice, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb
Country 135703 0
Croatia
Phone 135703 0
+385 1 3787 111
Fax 135703 0
Email 135703 0
[email protected]
Contact person for scientific queries
Name 135704 0
Matej Cindric
Address 135704 0
Clinical hospital center Sisters of charity, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb
Country 135704 0
Croatia
Phone 135704 0
+385 1 3787 111
Fax 135704 0
Email 135704 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24039Ethical approval    388161-(Uploaded-22-07-2024-05-09-31)-Dok10.pdf



Results publications and other study-related documents

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