NCT05644483

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Remimazolam	Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)
DRUG	Propofol	Propofol: target controlled infusion: 2-3mcg/mL

Timeline

• Start date: 2022-03-29
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2022-12-09
• Last updated: 2025-02-26

Locations

1 site across 1 country: South Korea