Clinical trial NCT05414877: Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)
Official title: Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(MRI Part): a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carotid Endarterectomy
Keywords: carotid endarterectomy
ephedrine
phenylephrine
norepinephrine
cerebrovascular circulation
cerebral blood flow hemodynamics
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Carotid endarterectomy is a procedure used to remove plaque from the common and internal carotid arteries and improve cerebral perfusion. Clinical studies have demonstrated the effectiveness of this procedure in both symptomatic and asymptomatic patients. intraoperative circulatory management challenges in CEA include the following: ① The incidence of preoperative combined coronary artery disease, hypertension and diabetes mellitus is relatively high in patients undergoing carotid endarterectomy, and there is a pathological basis for systemic vascular injury, increasing the risk of perioperative cardiovascular and cerebrovascular complications, such as myocardial ischemia and stroke. ② During the CEA procedure, the common carotid artery, internal carotid artery and external carotid artery and the superior thyroid artery need to be blocked respectively, the source of blood supply to the cerebral hemisphere on the operated side is reduced and depends only on the Willis circle supply. ③ Carotid sinus pressure receptor pull stimulation causes circulatory fluctuations. During CEA, a relatively high arterial pressure is required to provide adequate cerebral perfusion. However, achieving this target blood pressure level intraoperatively can be challenging due to given conditions, the presence of induction drugs and anesthetics. Therefore, it is particularly important to maintain cerebral hemodynamic stability and ensure tissue perfusion with intraoperative use of vasopressers.

The purpose of this study was to evaluate the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamic in CEA patients using DSC-MRI to investigate the specific mechanisms of the three boosting agents on cerebral blood flow and oxygen metabolism in brain tissues.

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

Primary outcomes:
measure: Regional Cerebral Blood Flow
timeFrame: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Secondary outcomes:
measure: Regional oxygen saturation index
timeFrame: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology，Beijing Tiantan Hospital, Capital Medical University
name: Ruquan Ruquan, M.D.,PhD
role: STUDY_CHAIR
References: