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Trial Title:
Effect of Preemptive Low Dose Norepinephrine Infusion on Intraoperative Hemodynamic Stability and Postoperative Outcomes in Patients Undergoing Brain Tumor Resection With a Craniotomy
NCT ID:
NCT05814601
Condition:
Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Norepinephrine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
norepinephrine
Description:
norepinephrine at a concentration of 5 mcg/ml is preemptively administered
Arm group label:
experimental group
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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yonsei University College of Medicine
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
Hye Jin Kim
Phone:
82-2-2224-4464
Email:
jackiedi@yuhs.ac
Start date:
May 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05814601
