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OpenTrials
Completed

NCT Number: NCT05164146

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

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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Key information

Conditions

Patients Undergoing Neurosurgery

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Remimazolam

Drug

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

Primary outcomes

  1. 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

  1. blood pressure

    Time frame: procedure (during induction before the surgery)

    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.

  2. heart rate

    Time frame: procedure (during induction before the surgery)

    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.

  3. sedline psi

    Time frame: procedure (during induction before the surgery)

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2021
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.