Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05414877
Collaborator
(none)
60
3
30.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(MRI Part): a Randomized Controlled Study
Anticipated Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ephedrine

receive ephedrine (configured concentration 2 mg/mL). The individualized blood pressure control target was a 20% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Drug: Ephedrine
vasopressor

Experimental: Phenylephrine

receive intravenous infusion of phenylephrine (configured concentration 0.1 mg/mL) The individualized blood pressure control target was a 20% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Drug: Phenylephrine
vasopressor

Experimental: norepinephrine

intravenous infusion of norepinephrine (configured concentration of 6 μg/ml).The individualized blood pressure control target was a 20% increase in baseline blood pressure, and the target blood pressure value was used as the basis for adjusting the dosing or pumping rate.

Drug: Norepinephrine
vasopressor

Outcome Measures

Primary Outcome Measures

  1. Regional Cerebral Blood Flow [10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors]

    This outcome is measured by Dynamic susceptibility contrast-enhanced perfusion-weighted imaging.

Secondary Outcome Measures

  1. Regional oxygen saturation index [10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors]

    This outcome is measured by Near Infrared Spectroscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

  • Study Chair: Ruquan Ruquan, M.D.,PhD, Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruquan Han, Professor & Director, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT05414877
Other Study ID Numbers:
  • wxy20220526
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ruquan Han, Professor & Director, Beijing Tiantan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022