Carotid EndarterectomyNCT05414877
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)
A study testing Ephedrine, Phenylephrine and Norepinephrine in people with Carotid Endarterectomy, run by Beijing Tiantan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Endarterectomy
- What is being tested?
- Ephedrine, Phenylephrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-80 years.
- elective carotid endarterectomy.
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carotid Endarterectomy
- Being tested
- Ephedrine, Phenylephrine, Norepinephrine
- Keywords
- carotid endarterectomy, ephedrine, phenylephrine, norepinephrine, cerebrovascular circulation, cerebral blood flow hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
vasopressor
PhenylephrineDrug
vasopressor
NorepinephrineDrug
vasopressor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral Blood Flow
This outcome is measured by Dynamic susceptibility contrast-enhanced perfusion-weighted imaging.
Measured: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Secondary outcomes (1)
Regional oxygen saturation index
This outcome is measured by Near Infrared Spectroscopy
Measured: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start30 Sep 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid EndarterectomyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Ruquan, M.D.,PhD, Study chair, Department of Anesthesiology，Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414877
- Sponsor's protocol ID
- wxy20220526
- Status last verified
- Aug 2023
- First submitted
- 26 May 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(MRI Part): a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05414877
- Acronym / sponsor ID
- wxy20220526
- Conditions
- Carotid Endarterectomy
- Keywords
- carotid endarterectomy, ephedrine, phenylephrine, norepinephrine, cerebrovascular circulation, cerebral blood flow hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | Experimental | Drug: Ephedrinereceive 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. |
| Phenylephrine | Experimental | Drug: Phenylephrinereceive 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. |
| norepinephrine | Experimental | Drug: Norepinephrineintravenous 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 40-80 years.
- elective carotid endarterectomy.
- Signed informed consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ephedrinevasopressor | Drug | Ephedrine |
| Phenylephrinevasopressor | Drug | Phenylephrine |
| Norepinephrinevasopressor | Drug | norepinephrine |
Primary outcome
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.
1 secondary outcome
Regional oxygen saturation index
Time frame: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruquan Ruquan, M.D.,PhD study chair
Department of Anesthesiology，Beijing Tiantan Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Ephedrine, Phenylephrine and Norepinephrine in people with Carotid Endarterectomy, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D.,PhD (01059976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Cerebral Blood Flow (time frame: 10 minutes after entering the operating room; 10 minutes after intubation ;5 minutes after administration of vasopressors). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.