Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy

Yonsei University

Status: Completed

Conditions: Prostate Tumor

Treatments: Drug: Propofol; Drug: remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06093971

4-2023-0803

Details and patient eligibility

About

The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure <65mmHg is defined as hypotension).

Enrollment: 112 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.

Exclusion criteria

1. emergency surgery
2. If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.)
3. cognitive dysfunction
4. Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less
5. Patients who did not take renin-angiotensin system blockers on the day of surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

112 participants in 2 patient groups

Group remimazolam

Experimental group

Description:

During anesthesia induction, the remimazolam group (group R) receives remimazolam (0.2 mg/kg). If necessary, an additional dose of remimazolam (0.1 mg/kg) is administered.

Treatment:

Drug: remimazolam

Group propofol

Active Comparator group

Description:

During anesthesia induction, the propofol group (group P) receives propofol (1.0 mg/kg). If necessary, an additional dose of propofol (0.5 mg/kg) is administered.

Treatment:

Drug: Propofol