Effects of remimazolam and propofol on circulatory dynamics via mean circulatory filling pressure

JRCT ID: jRCT1011240069

Registered date:29/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients after induction of general anesthesia
• Date of first enrollment: 29/01/2025
• Target sample size: 66
• Study type: Interventional
• Intervention(s): Patients will be randomly assigned to one of two groups: the remimazolam group and the propofol group. Allocation will be by random assignment using Muzinwali. The allocation adjustment factors will be age, gender, BMI, and presence of comorbidities. Induction of general anesthesia will be performed using sedative drugs according to the above allocation.In the case of propofol, the induction is started at a blood concentration of 3.0 mcg/mL with a TCI pump. in the case of remimazolam, the induction is started at 12 mg/kg/hr, and both are adjusted to achieve a BIS value between 40 and 60 after bed rest. After 30 minutes of anesthesia induction, 4 mL/kg of extracellular fluid is administered.

Outcome(s)

• Primary Outcome: Pmcf values before induction of general anesthesia, immediately after induction, 30 minutes after induction, and after infusion load

Secondary Outcome

Blood pressure, pulse rate, oxygen saturation (SpO2), body temperature, cardiac output (CO), single cardiac output (SV), cardiac coefficient of index (CCI), body vascular resistance (SVR), blood gas analysis, and bispectral index (BIS) values before, immediately after, 30 minutes after induction, and after infusion load
Total dose of remimazolam and propofol up to the end of infusion load and up to the end of anesthesia
Total dose of fentanyl and remifentanil up to the end of infusion load and up to the end of anesthesia
Patient background (age, gender, weight, ASA-PS, underlying disease, and medications)
Incidence of adverse events in the 24-hour postoperative period (hypoxic events (SpO2<92%), ischemic heart disease, stroke, nausea and vomiting, and number of antiemetic medications used)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients scheduled to undergo standby surgery under general anesthesia in the operating room of Sapporo Medical University Hospital.
2) The patient is scheduled to undergo arterial pressure monitoring using an arterial line under general anesthesia.
3) Adults aged 20 years or older at the time of surgery.
4) The patient's preoperative condition should be ASA-PS (American Society of Anesthesiologists Physical Status) 1-2 and in good general condition.

Exclude criteria

(1) Patients with contraindications to propofol or remimazolam
(2) Patients who are allergic to propofol, remimazolam, midazolam, or flumazenil.
(3) Patients who are allergic to propofol, remimazolam, midazolam, or flumazenil.
(4) Patients with severe hepatic or renal dysfunction that may affect drug metabolism.
(5) Patients with severe hepatic or renal dysfunction that may affect drug metabolism (5) Other patients who are judged inappropriate for participation in this study by the principal investigators and sub-investigators

Related Information

• Primary Sponsor: Yamakage Michiaki