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

Yonsei University

Status: Completed

Conditions: Patients Undergoing Neurosurgery

Treatments: Drug: propofol; Drug: remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05164146

4-2021-1456

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

propofol group

Active Comparator group

Description:

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

Treatment:

Drug: propofol

remimazolam group

Experimental group

Description:

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

Treatment:

Drug: remimazolam