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

Primary Purpose

Patients Undergoing Neurosurgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol
remimazolam
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients Undergoing Neurosurgery

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

propofol group

remimazolam group

Arm Description

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

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

Outcomes

Primary Outcome Measures

incidence of hypotension events
Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 15, 2021
Last Updated
November 3, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05164146
Brief Title
The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
Official Title
The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Neurosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propofol group
Arm Type
Active Comparator
Arm Description
During the induction, propofol was controlled according to sedline (Psi target 40)
Arm Title
remimazolam group
Arm Type
Experimental
Arm Description
During induction, remimazolam dose was controlled according to sedline (Psi target 40)
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
during the induction, remimazolam dose was controlled according to sedline (Psi target 40)
Intervention Type
Drug
Intervention Name(s)
remimazolam
Intervention Description
During induction, remimazolam dose was controlled according to sedline (Psi target 40)
Primary Outcome Measure Information:
Title
incidence of hypotension events
Description
Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.
Time Frame
procedure (during induction before the surgery)
Secondary Outcome Measure Information:
Title
blood pressure
Description
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.
Time Frame
procedure (during induction before the surgery)
Title
heart rate
Description
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.
Time Frame
procedure (during induction before the surgery)
Title
sedline psi
Description
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.
Time Frame
procedure (during induction before the surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujung Park
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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