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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. emergency surgery. 2. If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.) 3. cognitive dysfunction. 4. pregnant, lactating. 5. Congestive heart failure (New York Heart Association scores ≥3) 6. arrhythmia. 7. Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2) 8. Patients with severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, asthma under treatment, etc.) 9. Uncontrolled hypertension (baseline blood pressure greater than 140/90)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05814601
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yonsei University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hye Jin Kim
Principal Investigator Affiliation	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor

Arms & Interventions

Arms

Experimental: experimental group

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

Interventions

Drug: - norepinephrine

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

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