NCT05814601

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

February 28, 2023

Last Update Submit

April 14, 2023

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (3)

  • 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

    during the total anesthesia duration (maximum up to 24 hours)

  • 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

    during the total anesthesia duration (maximum up to 24 hours)

  • 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

    during the total anesthesia duration (maximum up to 24 hours)

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: norepinephrine

Control group

NO INTERVENTION

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

Interventions

norepinephrineDRUG

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

experimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20 to 65 who undergo elective craniotomy for brain tumor resection

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Hye Jin Kim

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Jin Kim

CONTACT

82-2-2224-4464jackiedi@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

April 18, 2023

Study Start

May 1, 2023

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)