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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2022-08-10

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.

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Detailed Description

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Conditions

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Patients Undergoing Neurosurgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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propofol group

During the induction, propofol was controlled according to sedline (Psi target 40)

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

during the induction, remimazolam dose was controlled according to sedline (Psi target 40)

remimazolam group

During induction, remimazolam dose was controlled according to sedline (Psi target 40)

Group Type EXPERIMENTAL

remimazolam

Intervention Type DRUG

During induction, remimazolam dose was controlled according to sedline (Psi target 40)

Interventions

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propofol

during the induction, remimazolam dose was controlled according to sedline (Psi target 40)

Intervention Type DRUG

remimazolam

During induction, remimazolam dose was controlled according to sedline (Psi target 40)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. hypertension
2. patients undergoing neurosurgery
3. ASA I-III
4. 19-75 year-old patients

Exclusion Criteria

1. emergency
2. Patients admitted on the day of surgery
3. cardiac disease
4. liver failure or liver cirrhosis
5. increased intracranial pressure(IICP)
6. mental change
7. Foreigner
8. iliteracy

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes