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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05814601

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor	Drug: norepinephrine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect pf Preemptive Low Dose Norepinephrine Infusion on Hemodynamic Stability in Brain Tumor Resection

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group norepinephrine at a concentration of 5 mcg/ml is preemptively administered	Drug: norepinephrine norepinephrine at a concentration of 5 mcg/ml is preemptively administered
No Intervention: Control group norepinephrine at a concentration of 5 mcg/ml is not preemptively administered

Arm

Intervention/Treatment

Experimental: experimental group

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

Drug: norepinephrine

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

No Intervention: Control group

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

Outcome Measures

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 [during the total anesthesia duration (maximum up to 24 hours)]
The number of hemodynamic unstability occurred [during the total anesthesia duration (maximum up to 24 hours)]
※ 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 [during the total anesthesia duration (maximum up to 24 hours)]
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Hye Jin Kim, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05814601

Other Study ID Numbers:

4-2022-1619

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Neoplasms

Norepinephrine

Study Results

No Results Posted as of Apr 18, 2023