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Effect of Preemptive Low Dose Norepinephrine Infusion on Intraoperative Hemodynamic Stability and Postoperative Outcomes in Patients Undergoing Brain Tumor Resection With a Craniotomy

Primary Purpose

Brain Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
norepinephrine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Tumor

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 20 to 65 who undergo elective craniotomy for brain tumor resection Exclusion Criteria: emergency surgery If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.) cognitive dysfunction pregnant, lactating Congestive heart failure (New York Heart Association scores ≥3) arrhythmia Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2) Patients with severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, asthma under treatment, etc.) Uncontrolled hypertension (baseline blood pressure greater than 140/90)

Sites / Locations

  • Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

Control group

Arm Description

norepinephrine at a concentration of 5 mcg/ml is preemptively administered

norepinephrine at a concentration of 5 mcg/ml is not preemptively administered

Outcomes

Primary Outcome Measures

the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration
The number of hemodynamic unstability occurred
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure
The number of patients with hemodynamic unstability
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
April 14, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05814601
Brief Title
Effect of Preemptive Low Dose Norepinephrine Infusion on Intraoperative Hemodynamic Stability and Postoperative Outcomes in Patients Undergoing Brain Tumor Resection With a Craniotomy
Official Title
Effect pf Preemptive Low Dose Norepinephrine Infusion on Hemodynamic Stability in Brain Tumor Resection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

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
In the experimental group, norepinephrine at a concentration of 5 mcg/ml is preemptively administered through peripheral venous catheter with a size of 20 G or more from the time of anesthesia induction to the end of anesthetic administration. The norepinephrine is not preemptively administered in the control group. For anesthesia, total intravenous anesthesia using propofol and remifentanil is performed. During anesthesia, the injection rate of the test drug is allowed to be adjusted according to the blood pressure within the permissible range, and anesthesia management such as fluid infusion, blood transfusions, and drug administration is performed according to the judgment of the anesthesiologist, and there are no restrictions. The achievement of hemodynamic stability during anesthesia is judged by the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration. The number of hemodynamic unstability occurred, and the number of patients with hemodynamic unstability are also sought. The incidence of postoperative complications between the two groups is also compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
norepinephrine at a concentration of 5 mcg/ml is preemptively administered
Arm Title
Control group
Arm Type
No Intervention
Arm Description
norepinephrine at a concentration of 5 mcg/ml is not preemptively administered
Intervention Type
Drug
Intervention Name(s)
norepinephrine
Intervention Description
norepinephrine at a concentration of 5 mcg/ml is preemptively administered
Primary Outcome Measure Information:
Title
the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration
Time Frame
during the total anesthesia duration (maximum up to 24 hours)
Title
The number of hemodynamic unstability occurred
Description
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure
Time Frame
during the total anesthesia duration (maximum up to 24 hours)
Title
The number of patients with hemodynamic unstability
Description
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure
Time Frame
during the total anesthesia duration (maximum up to 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20 to 65 who undergo elective craniotomy for brain tumor resection Exclusion Criteria: emergency surgery If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.) cognitive dysfunction pregnant, lactating Congestive heart failure (New York Heart Association scores ≥3) arrhythmia Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2) Patients with severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, asthma under treatment, etc.) Uncontrolled hypertension (baseline blood pressure greater than 140/90)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Jin Kim
Phone
82-2-2224-4464
Email
jackiedi@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Jin Kim
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Jin Kim
Phone
82-2-2224-4464
Email
jackiedi@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Preemptive Low Dose Norepinephrine Infusion on Intraoperative Hemodynamic Stability and Postoperative Outcomes in Patients Undergoing Brain Tumor Resection With a Craniotomy

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