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Clinical Trials/NCT05164146
NCT05164146
Completed
Not Applicable

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

Yonsei University1 site in 1 country100 target enrollmentFebruary 23, 2022

Overview

Phase
Not Applicable
Intervention
propofol
Conditions
Patients Undergoing Neurosurgery
Sponsor
Yonsei University
Enrollment
100
Locations
1
Primary Endpoint
incidence of hypotension events
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2022
End Date
August 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • hypertension
  • patients undergoing neurosurgery
  • 19-75 year-old patients

Exclusion Criteria

  • Patients admitted on the day of surgery
  • cardiac disease
  • liver failure or liver cirrhosis
  • increased intracranial pressure(IICP)
  • mental change

Arms & Interventions

propofol group

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

Intervention: propofol

remimazolam group

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

Intervention: remimazolam

Outcomes

Primary Outcomes

incidence of hypotension events

Time Frame: procedure (during induction before the surgery)

Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.

Secondary Outcomes

  • blood pressure(procedure (during induction before the surgery))
  • heart rate(procedure (during induction before the surgery))
  • sedline psi(procedure (during induction before the surgery))

Study Sites (1)

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