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

Not Applicable

Completed

• Conditions: Prostate Tumor
• Interventions: Drug: remimazolam; Drug: Propofol

• Registration Number: NCT06093971
• Lead Sponsor: Yonsei University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-23
• Study Start: 2023-11-17
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group remimazolam	remimazolam	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.
Group propofol	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Hypotension occurrence (unit: number of patients)	during the total anesthesia duration	"MAP\<65mmHg for 1 min
Vasopressor dose (unit: mcg for norepinephrine)	during the total anesthesia duration	total dose of norepinephrine administered
Amount of hypotension (unit: mmHg)	during the total anesthesia duration	time-weighted average MAP \<65mmHg =\> depth of hypotension (mmHg) below a MAP of 65 mmHg \* time (min) below a MAP of 65 mmHg)/ total duration of surgery (min)
Vasopressor dose (unit for vasopressin)	during the total anesthesia duration	total dose of vasopressin administered

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of