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Comparing the safety and effectiveness of remimazolam and propofol for general anesthesia.

Comparing the safety and effectiveness of remimazolam and propofol for general anesthesia in patients subject to surgery.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001124527
Enrollment
60
Registered
2024-09-18
Start date
2024-09-24
Completion date
2025-02-17
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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

Sponsors

University Hospital Center Sestre milosrdnice
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

ASA II and III status. Age 18 years and over, Elective endocholecystectomia surgery.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026