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

NCT05665881 | Completed DMC

• 1 other identifier: wxy20220513
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 patients undergoing carotid endarterectomy were evaluated using TCD techniques 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)

• Changes in middle cerebral artery blood velocity

  This outcome is measured by transcranial doppler ultrasound.

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

Secondary Outcomes (1)

• Changes in 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

Ephedrine group: receive ephedrine (configured concentration 2 mg/mL). The individualized blood pressure control target was a 10% 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

Phenylephrine group: receive intravenous infusion of phenylephrine (configured concentration 0.1 mg/mL) The individualized blood pressure control target was a 10% 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

norepinephrine group: intravenous infusion of norepinephrine (configured concentration of 6 μg/ml).The individualized blood pressure control target was a 10% 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:

• American Society of Anesthesiologists physical status classification (ASA) 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

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location

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 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: December 27, 2022
• Study Start: January 7, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)