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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06093971

Collaborator

(none)

112

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Tumor	Drug: remimazolam Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 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.	Drug: remimazolam Remimazolam is administered for anesthesia induction.
Active Comparator: Group 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.	Drug: Propofol Propofol is administered for anesthesia induction.

Arm

Intervention/Treatment

Experimental: Group 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.

Drug: remimazolam

Remimazolam is administered for anesthesia induction.

Active Comparator: Group 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.

Drug: Propofol

Propofol is administered for anesthesia induction.

Outcome Measures

Primary Outcome Measures

Hypotension incidence (unit: event number) [during the total anesthesia duration]
mean arterial pressure (MAP)<65 mmHg for 5 min
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: mcg for norepinephrine) [during the total anesthesia duration]
total dose of norepinephrine administered
Vasopressor dose (unit for vasopressin) [during the total anesthesia duration]
total dose of vasopressin administered

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Male

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: So Yeon Kim, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT06093971

Other Study ID Numbers:

4-2023-0803

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Propofol

Study Results

No Results Posted as of Oct 23, 2023