Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Effect of Remimazolam-remifentanil Versus Propofol-remifentanil Based General Anesthesia on Intraoperative Hemodynamic Stability in Prone Position for Major Spine Surgery: a Randomized Controlled Trial

Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA physical status: 1-3
• age: 19-80 years
• patients who are scheduled to undergo a major spine surgery in the prone position

Exclusion Criteria:

• patients who refuse to participate
• body mass index: <15kg/m2 or >35kg/m2
• patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease
• patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication
• allergic to propofol and midazolam
• patients who are judged unsuitable to participate in the study for other reasons by medical staffs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remimazolam group; patients who receive remimazolam-remifentanil based total intravenous anesthesia	Drug: Remimazolam; Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)
Active Comparator: propofol group; patients who receive propofol-remifentanil based total intravenous anesthesia	Drug: Propofol; Propofol: target controlled infusion: 2-3mcg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of hypotensive episode per patient	SAP < baseline SBP * 80% or 90mmHg // MAP < baseline MAP * 80% or 65mmHg	for one hour after turning the patients to the prone position
the number of severe hypotensive episode per patient	SAP < baseline SBP * 70% or 80mmHg // MAP < baseline MAP * 70% or 55mmHg	for one hour after turning the patients to the prone position

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac index	cardiac index from Flotrac	for one hour after turning the patients to the prone position
pleth variability index	pleth variability index	for one hour after turning the patients to the prone position
heart rate	heart rate from EKG	for one hour after turning the patients to the prone position
Total opioid consumption	amount of total opioid administered	for one hour after turning the patients to the prone position
cardiac output	cardiac output from Flotrac	for one hour after turning the patients to the prone position
stroke volume	stroke volume from Flotrac	for one hour after turning the patients to the prone position
stroke volume variation	stroke volume variation from Flotrac	for one hour after turning the patients to the prone position

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: propofol; remimazolam
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: 2021-1514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No