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

NCT05414877 | Unknown DMC

• 1 other identifier: wxy20220526
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carotid Endarterectomy

Keywords

carotid endarterectomy; ephedrine; phenylephrine; norepinephrine; cerebrovascular circulation; cerebral blood flow hemodynamics

Outcome Measures

Primary Outcomes (1)

• Regional Cerebral Blood Flow

  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 Outcomes (1)

• Regional oxygen saturation index

  10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors

Study Arms (3)

Ephedrine

EXPERIMENTAL

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

Phenylephrine

EXPERIMENTAL

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

norepinephrine

EXPERIMENTAL

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

Interventions

Ephedrine DRUG

vasopressor

Ephedrine

Phenylephrine DRUG

vasopressor

Phenylephrine

Norepinephrine DRUG

vasopressor

norepinephrine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 40-80 years.
• elective carotid endarterectomy.
• Signed informed consent

You may not qualify if:

• ASA classification IV - VI.
• renal failure (estimated glomerular filtration rate less than 60 ml/min.m2).
• cardiac arrhythmias.
• Allergy to ephedrine, phenylephrine or norepinephrine, gadobutrol.
• patients with preoperative TCD suggesting poor temporal window signal.
• patients with severe carotid artery stenosis with no flow signal detected by TCD
• Patients with tandem lesions of carotid artery stenosis

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Interventions

Ephedrine; Phenylephrine; Norepinephrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ruquan Ruquan, M.D.,PhD

  Department of Anesthesiology，Beijing Tiantan Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

Ruquan Han, M.D.,PhD

CONTACT

01059976660; ruquan.han@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Director

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 10, 2022
• Study Start: September 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08