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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

General anesthesia

Condition category

Condition code

Anaesthesiology

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]

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]

Anesthesia depth determined by BIS score

Timepoint [1]

BIS values will be assessed for every 5 minutes during the procedure until the values reach awake state (BIS >80).

Primary outcome [2]

Anesthesia depth determined by PSI score

Timepoint [2]

PSI values will be assessed for every 5 minutes during the procedure until the values reach awake state (PSI>50)

Secondary outcome [1]

Haemodynamics

Timepoint [1]

Before the induction of anesthesia and every 5 minutes during the procedure

Secondary outcome [2]

Haemodynamics

Timepoint [2]

Before the induction of anesthesia and every 5 minutes during the procedure

Secondary outcome [3]

Haemodynamics

Timepoint [3]

Before the induction of anesthesia and every 5 minutes during the procedure.

Secondary outcome [4]

Depth of sedation.

Timepoint [4]

Before the induction of anesthesia and every 5 minutes during the procedure.

Secondary outcome [5]

Recovery of anesthesia

Timepoint [5]

One hour after the procedure is done.

Secondary outcome [6]

Quality of recovery after surgery and anesthesia

Timepoint [6]

24 hours after the procedure.

Secondary outcome [7]

Induction of anesthesia time

Timepoint [7]

At the induction of anesthesia

Secondary outcome [8]

Time to fully awake from anesthesia

Timepoint [8]

After the discontinuation of the drugs.

Secondary outcome [9]

Drug dosage

Timepoint [9]

During the procedure.

Secondary outcome [10]

Time to fully awake from anesthesia

Timepoint [10]

After the discontinuation of the drugs.

Secondary outcome [11]

Induction of anesthesia time

Timepoint [11]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Croatia

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

University Hospital Center Sestre milosrdnice

Address [1]

Country [1]

Croatia

Primary sponsor type

Hospital

Name

University Hospital Center Sestre milosrdnice

Address

Country

Croatia

Secondary sponsor category [1]

Hospital

Name [1]

University Hospital Center Sestre milosrdnice

Address [1]

Country [1]

Croatia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of University Hospital Center Sestre milosrdnice

Ethics committee address [1]

University Hospital Center Sestre milosrdnice, Vinogradsa c. 29, 10000 Zagreb, Croatia

Ethics committee country [1]

Croatia

Date submitted for ethics approval [1]

01/07/2024

Approval date [1]

09/07/2024

Ethics approval number [1]

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

Dr Matej Cindric

Address

Clinical hospital center Sestre milosrdnice, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb

Country

Croatia

Phone

+385 1 3787 111

Fax

[email protected]

Contact person for public queries

Name

Matej Cindric

Address

Clinical hospital center Sestre milosrdnice, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb

Country

Croatia

Phone

+385 1 3787 111

Fax

[email protected]

Contact person for scientific queries

Name

Matej Cindric

Address

Clinical hospital center Sisters of charity, Department of anesthesiology, Vinogradska cesta 29, 10000 Zagreb

Country

Croatia

Phone

+385 1 3787 111

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24039	Ethical approval					388161-(Uploaded-22-07-2024-05-09-31)-Dok10.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.

Trial Review

Documents added manually

Documents added automatically