Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Phase 4

Recruiting

• Conditions: Hemodynamic Instability
• Interventions: Drug: Propofol; Drug: Remimazolam

• Registration Number: NCT05644483
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-03
• Study Start: 2022-03-29
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	Propofol	patients who receive propofol-remifentanil based total intravenous anesthesia
remimazolam group	Remimazolam	patients who receive remimazolam-remifentanil based total intravenous anesthesia

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of