Clinical trial

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(MRI Part): a Randomized Controlled Study

Name
wxy20220526
Description
This study was a single-center, exploratory, randomized controlled trial. First, the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamics in CEA patients were evaluated using DSC-MRI to investigate the specific mechanisms of the three vasopressors on cerebral blood flow and oxygen metabolism in brain tissues.
Trial arms
Trial start
2023-09-30
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Ephedrine
vasopressor
Arms:
Ephedrine
Phenylephrine
vasopressor
Arms:
Phenylephrine
Norepinephrine
vasopressor
Arms:
norepinephrine
Size
60
Primary endpoint
Regional Cerebral Blood Flow
10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Eligibility criteria
Inclusion Criteria: 1. age 40-80 years. 2. elective carotid endarterectomy. 3. Signed informed consent Exclusion Criteria: 1. ASA classification IV - VI. 2. renal failure (estimated glomerular filtration rate less than 60 ml/min.m2). 3. cardiac arrhythmias. 4. Allergy to ephedrine, phenylephrine or norepinephrine, gadobutrol. 5. patients with preoperative TCD suggesting poor temporal window signal. 6. patients with severe carotid artery stenosis with no flow signal detected by TCD 7. Patients with tandem lesions of carotid artery stenosis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "This study could not be blinded to the treating anesthesiologists. However, blinding was maintained for the patients and the assessors of outcome indicators. Postoperative follow-up was performed by a specially trained physician who did not have access to any information about the patients' cases and subgroups.", 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-08-24

1 organization

3 products

1 indication

Product
Ephedrine