HypotensionPhase 4NCT06257316
Appropriate Dosage of Vasopressor in Neonates and Infants
A Phase 4 study testing EPHEDrine Hydrochloride 5 mg/ml in people with Hypotension and Neonatal Hypotension, run by Seoul National University Hospital.
Trial summary
In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Hypotension, Neonatal Hypotension, Intraoperative Complications
- What is being tested?
- EPHEDrine Hydrochloride 5 mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 28 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns and infants under 2 years of age undergoing surgery under general anesthesia at Seoul National University Hospital
Who cannot join
- Premature infants with a gestational age of less than 37 weeks
- Children with a history of brain disease (hydrocephalus, brain tumor, etc.)
- Patients with a history of hypoxic/ischemic brain injury
- Children with fused fontanels
- Children with uncorrected congenital cardiac malformations such as patent ductus arteriosus
- Patients with hypersensitivity to ephedrine and its components
Show all 21Show fewer
- Patients with hypertension
- Patients with thyrotoxicosis
- Patients with renal impairment and those taking thyroid medication
- Glaucoma patients
- Diabetic patients
- Patients with prostatic hyperplasia
- Patients with chromophobe cell tumors
- Patients taking or within 2 weeks of discontinuing monoamine oxidase inhibitors
- Patients with ischemic heart disease
- Patients receiving foxglove preparations
- Patients with cardiac disease
- Patients receiving inotropic agents and those with abnormal baseline blood pressure
- Those who are taking or need to take concomitant contraindicated medications
- Those who require halogenated anesthetics such as chloroform, cyclopropane, and halothane because concomitant administration may cause ventricular arrhythmias.
- Those who are expected to require these agents because they may cause arrhythmias or cardiac arrest when coadministered with catecholamines such as epinephrine and isoproterenol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Appropriate Dosage of Vasopressors to Maintain Adequate Cerebral Blood Flow During Surgery and Anesthesia in Neonates and Infants
In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.
Read the detailed description
Improvements in surgical techniques and perioperative care in the neonate have resulted in a significant improvement in survival rates, with the mortality rate for neonatal noncardiac surgery being less than 5% in 2013, compared to 72% in 1947. As survival rates have improved, the question of long-term prognosis, especially concerning delayed cranial nerve development and subsequent quality of life, has emerged. In 48% of full-term infants undergoing non-cardiac surgery in the neonatal period for major congenital conditions (diaphragmatic hernia, esophageal atresia, abdominal wall defects, congenital megacolon, etc.) and 75% of preterm infants, brain damage is identified on post-operative brain MRI, and developmental testing reveals cognitive impairment in 3-56% and motor impairment in 0-77%.
motor disorders in 3-56% and 0-77%. Cognitive and motor deficits are known to occur in 45% of patients undergoing non-cardiac surgery for congenital conditions, excluding neurodevelopmental disorders caused by the concomitant congenital genetic disease itself.
Cerebral perfusion is regulated by arterial baroreflex, cerebral blood flow autoregulation, and flow metabolism, which are immature in the neonate and are lost under general anesthesia. This can lead to intraoperative changes in blood pressure, carbon dioxide concentration, intraventricular hemorrhage, and lateral ventricular hemorrhagic infarction, which can cause brain damage.
According to the Anaesthesia Practice in Children Observational Trial study, 32% of children undergoing general anesthesia and surgery develop hypotension that requires inotropes. The goal of maintaining arterial blood pressure at a constant level in infants during surgery is to maintain blood flow to vital organs, including the brain. However, there is a lack of evidence on what blood pressure should be maintained to maintain adequate cerebral perfusion in infants and how much hypotension is acceptable. The current definition of normal blood pressure in infants is based on birth weight and gestational age. For example, if the gestational age is 36 weeks, the recommendation is to maintain a mean arterial pressure of 36 mm Hg or higher. However, studies have shown that mean arterial pressure below this level does not affect prognosis as long as adequate perfusion is maintained. Furthermore, raising blood pressure to maintain normotension based on gestational age may lead to intraventricular hemorrhage. A recent study was published to determine the appropriate dose of ephedrine in infants with intraoperative hypotension and found that a higher dose (1.2 mg/kg) than the adult dose (0.1 mg/kg) was required to raise blood pressure, but the study was limited by the lack of confirmation of how raising blood pressure changes cerebral blood flow. Therefore, in this study, the investigators aimed to determine the changes in cerebral blood flow according to the dose of ephedrine infusion in neonates and infants as measured by the changes in blood flow in the internal carotid artery using transcranial ultrasound and to suggest blood pressure standards and ephedrine dosage for maintaining adequate cerebral blood flow in neonates and infants.
- Being tested
- EPHEDrine Hydrochloride 5 mg/ml
- Medical subject headings
- Hypotension, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPHEDrine Hydrochloride 5 mg/mlDrug
In the present study, the expected rate of recovery of the internal carotid artery according to the dose of the inotropic agent was similar to that in a previous study in which the fraction maintaining mean arterial pressure within 80% of baseline by dose of inotropic agent was 0.9% for the ephedrine 0.1, 0.6, 0.8, 1. 0, 1.2, and 1.4 doses (mg/kg) were 9.9%, 21%, 41%, 47%, 65.5%, and 40%, respectively (Br J Anaesth. 2023 May;130(5):603-610), and it was assumed that the rate of internal carotid artery recovery by inotrope dose would be 90% of that result.
The study will randomize to dose in six cohorts and will include dose group and cohort variables in a logistic regression model to assess the trend between inotropic dose and rate of carotid revascularization after correcting for cohort effects on the outcome variable.
| Study group | Role | What they receive |
|---|---|---|
| 0.1mg/kg of ephedrine | Active comparator | If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.
Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, 1.2 mg/kg.
Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. Receives: Drug: EPHEDrine Hydrochloride 5 mg/ml |
| 0.2mg/kg of ephedrine | Active comparator | If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.
Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, 1.2 mg/kg.
Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. Receives: Drug: EPHEDrine Hydrochloride 5 mg/ml |
| 0.3mg/kg of ephedrine | Active comparator | If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.
Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg.
Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. Receives: Drug: EPHEDrine Hydrochloride 5 mg/ml |
| 0.5mg/kg of ephedrine | Active comparator | If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.
Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg.
Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. Receives: Drug: EPHEDrine Hydrochloride 5 mg/ml |
| 1.0mg/kg of ephedrine | Active comparator | If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.
Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg.
Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. Receives: Drug: EPHEDrine Hydrochloride 5 mg/ml |
| 1.2mg/kg of ephedrine | Active comparator | If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.
Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg.
Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. Receives: Drug: EPHEDrine Hydrochloride 5 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of cerebral blood flow within 10 minutes
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 10 minutes of the bolus injection.
Measured: within 10 minutes after ephedrine injection
Secondary outcomes (7)
Recovery of cerebral blood flow within 2 minutes
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 2 minutes of the bolus injection.
Measured: within 2 minutes after ephedrine injection
Recovery of cerebral blood flow within 5 minutes
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 5 minutes of the bolus injection.
Measured: within 5 minutes after ephedrine injection
Recovery of mean arterial pressure within 10 minutes
Whether the mean arterial pressure recovers to at least 80% of the baseline value within 10 minutes of the bolus injection.
Measured: within 10 minutes after ephedrine injection
Additional durg dose
Type and dose of additional inotropes administered if mean arterial pressure does not return to at least 80% of baseline within 10 minutes of ephedrine injection.
Measured: within 10 minutes after ephedrine injection
electroencephalogram
Hemodynamic changes and their relationship to changes in cerebral oxygen saturation and electroencephalogram
Measured: from the induction of anesthesia to initiation of surgery
cerebral oxygen saturation
Hemodynamic changes and their relationship to changes in cerebral oxygen saturation and electroencephalogram
Measured: from the induction of anesthesia to initiation of surgery
fluid responsiveness
Determine if the presence of fluid responsiveness affects changes in cerebral blood flow induced by ephedrine injection
Measured: from the induction of anesthesia to initiation of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Seoul National University 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
- Investigators
- Eun-Hee Kim, M.D., Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257316
- Sponsor's protocol ID
- 2312-009-1489
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Appropriate Dosage of Vasopressors to Maintain Adequate Cerebral Blood Flow During Surgery and Anesthesia in Neonates and Infants
- ClinicalTrials.gov ID
- NCT06257316
- Acronym / sponsor ID
- 2312-009-1489
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 13 Feb 2024 (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.
In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.
Detailed description
Improvements in surgical techniques and perioperative care in the neonate have resulted in a significant improvement in survival rates, with the mortality rate for neonatal noncardiac surgery being less than 5% in 2013, compared to 72% in 1947. As survival rates have improved, the question of long-term prognosis, especially concerning delayed cranial nerve development and subsequent quality of life, has emerged. In 48% of full-term infants undergoing non-cardiac surgery in the neonatal period for major congenital conditions (diaphragmatic hernia, esophageal atresia, abdominal wall defects, congenital megacolon, etc.) and 75% of preterm infants, brain damage is identified on post-operative brain MRI, and developmental testing reveals cognitive impairment in 3-56% and motor impairment in 0-77%.
motor disorders in 3-56% and 0-77%. Cognitive and motor deficits are known to occur in 45% of patients undergoing non-cardiac surgery for congenital conditions, excluding neurodevelopmental disorders caused by the concomitant congenital genetic disease itself.
Cerebral perfusion is regulated by arterial baroreflex, cerebral blood flow autoregulation, and flow metabolism, which are immature in the neonate and are lost under general anesthesia. This can lead to intraoperative changes in blood pressure, carbon dioxide concentration, intraventricular hemorrhage, and lateral ventricular hemorrhagic infarction, which can cause brain damage.
According to the Anaesthesia Practice in Children Observational Trial study, 32% of children undergoing general anesthesia and surgery develop hypotension that requires inotropes. The goal of maintaining arterial blood pressure at a constant level in infants during surgery is to maintain blood flow to vital organs, including the brain. However, there is a lack of evidence on what blood pressure should be maintained to maintain adequate cerebral perfusion in infants and how much hypotension is acceptable. The current definition of normal blood pressure in infants is based on birth weight and gestational age. For example, if the gestational age is 36 weeks, the recommendation is to maintain a mean arterial pressure of 36 mm Hg or higher. However, studies have shown that mean arterial pressure below this level does not affect prognosis as long as adequate perfusion is maintained. Furthermore, raising blood pressure to maintain normotension based on gestational age may lead to intraventricular hemorrhage. A recent study was published to determine the appropriate dose of ephedrine in infants with intraoperative hypotension and found that a higher dose (1.2 mg/kg) than the adult dose (0.1 mg/kg) was required to raise blood pressure, but the study was limited by the lack of confirmation of how raising blood pressure changes cerebral blood flow. Therefore, in this study, the investigators aimed to determine the changes in cerebral blood flow according to the dose of ephedrine infusion in neonates and infants as measured by the changes in blood flow in the internal carotid artery using transcranial ultrasound and to suggest blood pressure standards and ephedrine dosage for maintaining adequate cerebral blood flow in neonates and infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.1mg/kg of ephedrine | Active comparator | Drug: EPHEDrine Hydrochloride 5 mg/mlIf the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered. Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, 1.2 mg/kg. Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. |
| 0.2mg/kg of ephedrine | Active comparator | Drug: EPHEDrine Hydrochloride 5 mg/mlIf the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered. Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, 1.2 mg/kg. Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. |
| 0.3mg/kg of ephedrine | Active comparator | Drug: EPHEDrine Hydrochloride 5 mg/mlIf the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered. Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg. Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. |
| 0.5mg/kg of ephedrine | Active comparator | Drug: EPHEDrine Hydrochloride 5 mg/mlIf the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered. Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg. Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. |
| 1.0mg/kg of ephedrine | Active comparator | Drug: EPHEDrine Hydrochloride 5 mg/mlIf the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered. Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg. Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. |
| 1.2mg/kg of ephedrine | Active comparator | Drug: EPHEDrine Hydrochloride 5 mg/mlIf the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered. Six single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg/kg. Initially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns and infants under 2 years of age undergoing surgery under general anesthesia at Seoul National University Hospital
Key exclusion criteria (21 listed)
- Premature infants with a gestational age of less than 37 weeks
- Children with a history of brain disease (hydrocephalus, brain tumor, etc.)
- Patients with a history of hypoxic/ischemic brain injury
- Children with fused fontanels
- Children with uncorrected congenital cardiac malformations such as patent ductus arteriosus
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 |
|---|---|---|
| EPHEDrine Hydrochloride 5 mg/mlIn the present study, the expected rate of recovery of the internal carotid artery according to the dose of the inotropic agent was similar to that in a previous study in which the fraction maintaining mean arterial pressure within 80% of baseline by dose of inotropic agent was 0.9% for the ephedrine 0.1, 0.6, 0.8, 1. 0, 1.2, and 1.4 doses (mg/kg) were 9.9%, 21%, 41%, 47%, 65.5%, and 40%, respectively (Br J Anaesth. 2023 May;130(5):603-610), and it was assumed that the rate of internal carotid artery recovery by inotrope dose would be 90% of that result. The study will randomize to dose in six cohorts and will include dose group and cohort variables in a logistic regression model to assess the trend between inotropic dose and rate of carotid revascularization after correcting for cohort effects on the outcome variable. | Drug | 0.1mg/kg of ephedrine, 0.2mg/kg of ephedrine, 0.3mg/kg of ephedrine, 0.5mg/kg of ephedrine, 1.0mg/kg of ephedrine, 1.2mg/kg of ephedrine |
Primary outcome
Recovery of cerebral blood flow within 10 minutes
Time frame: within 10 minutes after ephedrine injection
Whether at least one of the peak systolic velocity, end diastolic velocity, or velocity time integral of the internal carotid blood flow recovers to at least 80% of the baseline value within 10 minutes of the bolus injection.
7 secondary outcomes
Recovery of cerebral blood flow within 2 minutes
Time frame: within 2 minutes after ephedrine injection
Recovery of cerebral blood flow within 5 minutes
Time frame: within 5 minutes after ephedrine injection
Recovery of mean arterial pressure within 10 minutes
Time frame: within 10 minutes after ephedrine injection
Additional durg dose
Time frame: within 10 minutes after ephedrine injection
electroencephalogram
Time frame: from the induction of anesthesia to initiation of surgery
cerebral oxygen saturation
Time frame: from the induction of anesthesia to initiation of surgery
fluid responsiveness
Time frame: from the induction of anesthesia to initiation of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Eun-Hee Kim, M.D., Ph.D. study chair
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EPHEDrine Hydrochloride 5 mg/ml in people with Hypotension and Neonatal Hypotension, run by Seoul National University 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 1 inclusion and 21 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: opening soon, as of the sponsor's last update on 15 Feb 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eun-Hee Kim, M.D., Ph.D. (+82-2-2072-3664, beloveun@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of cerebral blood flow within 10 minutes (time frame: within 10 minutes after ephedrine injection). 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 15 Feb 2024.