The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery

Study Overview
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Brief Summary
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This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.

Official Title
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The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery

Conditions
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Patients Undergoing Neurosurgery

Intervention / Treatment
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* Drug: propofol
* Drug: remimazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hypertension patients undergoing neurosurgery ASA I-III 19-75 year-old patients Exclusion Criteria: emergency Patients admitted on the day of surgery cardiac disease liver failure or liver cirrhosis increased intracranial pressure(IICP) mental change Foreigner iliteracy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>During the induction, propofol was controlled according to sedline (Psi target 40) | Drug: propofol<br>* during the induction, remimazolam dose was controlled according to sedline (Psi target 40)<br>|
| Experimental: remimazolam group<br>During induction, remimazolam dose was controlled according to sedline (Psi target 40) | Drug: remimazolam<br>* During induction, remimazolam dose was controlled according to sedline (Psi target 40)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypotension events | Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure. | procedure (during induction before the surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | Blood pressure will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups. | procedure (during induction before the surgery) | 
| heart rate | heart rate will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups. | procedure (during induction before the surgery) | 
| sedline psi | sedline psi will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups. | procedure (during induction before the surgery) |