A comparative study of the effect of propofol and remimazolam on blood pressure during general anesthesia

JRCT ID: jRCT1011210026

Registered date:30/07/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: pancreatic cancer, hepatic cancer, bladder cancer, colon cancer, gastric cancer
• Date of first enrollment: 30/07/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

The patients will be randomly assigned to two groups: remimazolam and propofol. Random assignment will be performed using Mujinwari (URL: https://mujinwari.biz/users/login). Age, sex, BMI, and presence of hypertensive complications will be set as allocation adjustment factors. General anesthesia induction will be performed using sedative drugs according to the above allocation.
Propofol (administered intravenously using target control infusion to achieve a BIS value of 40-60, for 30 minutes from the start of anesthesia)
Remimazolam (administered at 12 mg/kg/h from the start of administration until bedtime, then intravenously at 1 mg/kg/h after bedtime for 30 minutes from the start of anesthesia)
Before and 30 minutes after induction of general anesthesia, the upper extremity on the indwelling side of the peripheral venous infusion circuit will be pressurized to 1.5 times the systolic blood pressure at the time of entry into surgery using a cuff pressure sphygmomanometer, and the mean circulatory filling pressure will be measured using a blood pressure monitor internal to the arterial line via a three-way stopcock in the peripheral venous infusion circuit.

Outcome(s)

• Primary Outcome: Changes in mean circulatory filling pressure before and after induction of general anesthesia and 30 minutes after induction of general anesthesia

Secondary Outcome

Patient background (age, gender, body weight, ASA PS, underlying diseases including hypertension, and presence of antihypertensive medication)
Changes in heart rate (HR) before and 30 minutes after induction of general anesthesia
Change in body blood pressure (NBP) before and 30 minutes after induction of general anesthesia
Transcutaneous arterial blood oxygen saturation (SpO2)
Changes in perfusion index (PI) before and 30 minutes after induction of general anesthesia
Change in the single cardiac output coefficient (esSVI) before and 30 minutes after induction of general anesthesia
Cardiac coefficient (esCCI) before and 30 minutes after induction of general anesthesia
Depth of anesthesia bispectral index (BIS) at each measurement time point
Total dose of remimazolam and propofol during induction of anesthesia
Incidence of adverse events: severe hypotension, use of hypertensive drugs, bradycardia, cardiac arrest

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) Patients scheduled to undergo open pancreaticoduodenectomy or liver resection surgery.
(3) The patient is scheduled to undergo arterial pressure monitoring using an arterial line under general anesthesia.
(4) Adults aged 20 years or older at the time of surgery.
(5) 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: Tomohiro Chaki