Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, remimazolam