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

August 22, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Cerebral Blood Flow
Time Frame: 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.
10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional oxygen saturation index
Time Frame: 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
10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wxy20220526

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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