Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

NCT05644483 | Completed Phase 4

• 1 other identifier: 2021-1514
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability

Keywords

propofol; remimazolam

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• cardiac index

  for one hour after turning the patients to the prone position

• pleth variability index

  for one hour after turning the patients to the prone position

• heart rate

  for one hour after turning the patients to the prone position

• Total opioid consumption

  for one hour after turning the patients to the prone position

• cardiac output

  for one hour after turning the patients to the prone position

Study Arms (2)

remimazolam group

EXPERIMENTAL

patients who receive remimazolam-remifentanil based total intravenous anesthesia

Drug: Remimazolam

propofol group

ACTIVE COMPARATOR

patients who receive propofol-remifentanil based total intravenous anesthesia

Drug: Propofol

Interventions

Remimazolam DRUG

Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)

remimazolam group

Propofol DRUG

Propofol: target controlled infusion: 2-3mcg/mL

propofol group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 9, 2022
• Study Start: March 29, 2022
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)