- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665881
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (TCD Part)
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(TCD Part): a Randomized Controlled Study
Study Overview
Status
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 carotid endarterectomy 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 vasopressors.
The purpose of this study was to evaluate the effects of ephedrine, phenylephrine, or norepinephrine on cerebral blood flow hemodynamics in CEA patients using TCD techniques to investigate the specific mechanisms of the three boosting agents on cerebral blood flow and oxygen metabolism in brain tissues.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruquan Han, MD
- Phone Number: 861059976660
- Email: ruquan.han@gmail.com
Study Locations
-
-
-
Beijing, China, 100070
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 40-80 years.
- elective carotid endarterectomy.
- Signed informed consent
Exclusion Criteria:
- 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
Study Plan
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
Ephedrine group: 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.
|
vasopressor
|
Experimental: Phenylephrine
Phenylephrine group: 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.
|
vasopressor
|
Experimental: norepinephrine
norepinephrine group: 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.
|
vasopressor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in middle cerebral artery blood velocity
Time Frame: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in 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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Norepinephrine
- Ephedrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- wxy20220513
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Carotid Endarterectomy
-
University of California, DavisCompletedEndarterectomy, CarotidUnited States
-
Washington University School of MedicineTerminatedCarotid EndarterectomyUnited States
-
Beijing Tiantan HospitalNot yet recruiting
-
Cleveland Clinic Abu DhabiRecruitingCarotid EndarterectomyUnited Arab Emirates
-
Baylor Research InstituteAdmedus Regen Pty Ltd.Completed
-
University Hospital, Strasbourg, FranceUnknown
-
Peking University Third HospitalCompletedCarotid Endarterectomy | Coronary Artery Bypass GraftingChina
-
Salzburger LandesklinikenCompletedIntermediate Cervical Plexus Block for Carotid EndarterectomyAustria
-
University of DebrecenUnknownCerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid EndarterectomyHungary
-
VA Office of Research and DevelopmentCompletedSurgery | Cholecystectomy, Laparoscopic | Arthroplasty, Replacement, Hip | Prostatectomy | Endarterectomy, CarotidUnited States
Clinical Trials on Ephedrine
-
Aswan UniversityCompletedCesarean Section Complications | Anesthesia | Subarachnoid BlockEgypt
-
Yuzuncu Yıl UniversityUnknown
-
Bursa Yüksek İhtisas Education and Research HospitalCompletedHypotension | UrolithiasisTurkey
-
Bayside HealthThe Alfred; Baker Heart and Diabetes InstituteUnknownObesity | Cardiovascular Disease | Type 2 DiabetesAustralia
-
Pennington Biomedical Research CenterAmgenCompleted
-
Hospital de BaseRecruitingHypotension | Spinal Anesthesia | Ephedrine | IntramuscularBrazil
-
Hospices Civils de LyonCompletedInfant, Newborn | Intraoperative Arterial HypotensionFrance
-
Weill Medical College of Cornell UniversityNew York Presbyterian HospitalCompletedNausea | Vomiting | Cesarean SectionUnited States
-
Shanghai Zhongshan HospitalUnknownGastrointestinal Bleeding | Gastrointestinal DiseaseChina
-
Bayside HealthCompleted