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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05814601
• Other study ID #: 4-2022-1619
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Yonsei University
• Contact: Hye Jin Kim
• Phone: 82-2-2224-4464
• Email: jackiedi[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)