Adverse EventNCT07894783
ED90 of Norepinephrine and Phenylephrine Infusion in Patients of Advanced Maternal Age
A study testing Norepinephrine and Phenylephrine in people with Adverse Event and Hypotension (MeSH: D007022), run by General Hospital of Ningxia Medical University.
Trial summary
This study aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method. Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Adverse Event, Hypotension (MeSH: D007022)
- What is being tested?
- Norepinephrine and Phenylephrine
- 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
- 31 Jan 2027to 31 Jan 2027
- Phase
- Interventional
- 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 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 35-40 years
- Full-term pregnancy
- American Society of Anesthesiologists physical status classification II
- Scheduled for cesarean section under spinal anesthesia
Who cannot join
- Body Mass Index ≥ 40 kg/m²;
- Confirmed maternal cardiovascular disorders (including hypertensive disorders of pregnancy and preeclampsia) as well as fetal developmental abnormalities;
- Fetal distress, or contraindications to spinal anesthesia including coagulation dysfunction and spinal malformations, etc.
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: ED90 of Norepinephrine and Phenylephrine Infusion for Prevention of Maternal Hypotension in Patients of Advanced Maternal Age Undergoing Cesarean Section: A Randomized Sequential Allocation Trial
This study aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method.
Read the detailed description
The proportion of pregnancies involving advanced maternal age has been increasing annually, and advanced maternal age itself is an independent high-risk factor for maternal hypotension following spinal anesthesia for cesarean delivery. Therefore, theoretically, the demand for vasopressors during spinal anesthesia in advanced maternal age patients should be higher. This study aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method.
- Conditions
- Adverse Event, Hypotension (MeSH: D007022)
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- Norepinephrine, Phenylephrine, Hypotension, Advanced maternal age, Cesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up down sequential allocation.
PhenylephrineDrug
An initial infusion dose of prophylactic norepinephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up down sequential allocation.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine group | Experimental | The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Receives: Drug: Norepinephrine |
| Phenylephrine group | Experimental | The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED90
The ED90 of norepinephrine and phenylephrine infusion for prevention of maternal hypotension under spinal anesthesia
Measured: 1-15 minutes after spinal anesthesia
Secondary outcomes (5)
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
Measured: 1-15 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) < 60% of the baseline
Measured: 1-15 minutes after spinal anesthesia.
pH
From umbilical arterial blood gases.
Measured: Immediately after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 1 minute after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 5 minute after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start31 Jan 2027 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Chen, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894783
- Sponsor's protocol ID
- Yi Chen-2026-3
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED90 of Norepinephrine and Phenylephrine Infusion for Prevention of Maternal Hypotension in Patients of Advanced Maternal Age Undergoing Cesarean Section: A Randomized Sequential Allocation Trial
- ClinicalTrials.gov ID
- NCT07894783
- Acronym / sponsor ID
- Yi Chen-2026-3
- Conditions
- Adverse Event, Hypotension (MeSH: D007022)
- Keywords
- Norepinephrine, Phenylephrine, Hypotension, Advanced maternal age, Cesarean section
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Oct 2026 (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 aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method.
Detailed description
The proportion of pregnancies involving advanced maternal age has been increasing annually, and advanced maternal age itself is an independent high-risk factor for maternal hypotension following spinal anesthesia for cesarean delivery. Therefore, theoretically, the demand for vasopressors during spinal anesthesia in advanced maternal age patients should be higher. This study aims to estimate the 90% effective dose (ED₉₀) of norepinephrine and phenylephrine infusions for the prevention of maternal hypotension in patients of advanced maternal age undergoing cesarean section, using the sequential allocation method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine group | Experimental | Drug: NorepinephrineThe maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. |
| Phenylephrine group | Experimental | Drug: PhenylephrineThe maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 35-40 years
- Full-term pregnancy
- American Society of Anesthesiologists physical status classification II
- Scheduled for cesarean section under spinal anesthesia
Key exclusion criteria (3 listed)
- Body Mass Index ≥ 40 kg/m²;
- Confirmed maternal cardiovascular disorders (including hypertensive disorders of pregnancy and preeclampsia) as well as fetal developmental abnormalities;
- Fetal distress, or contraindications to spinal anesthesia including coagulation dysfunction and spinal malformations, etc.
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 |
|---|---|---|
| NorepinephrineAn initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up down sequential allocation. | Drug | Norepinephrine group |
| PhenylephrineAn initial infusion dose of prophylactic norepinephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up down sequential allocation. | Drug | Phenylephrine group |
Primary outcome
ED90
Time frame: 1-15 minutes after spinal anesthesia
The ED90 of norepinephrine and phenylephrine infusion for prevention of maternal hypotension under spinal anesthesia
5 secondary outcomes
The incidence of post-spinal anesthesia hypotension
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension.
Time frame: 1-15 minutes after spinal anesthesia.
pH
Time frame: Immediately after delivery
APGAR score
Time frame: 1 minute after delivery
APGAR score
Time frame: 5 minute after delivery
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 26 Oct 2026.
- 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.
Yi Chen principal investigator
General Hospital of Ningxia Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Phenylephrine in people with Adverse Event and Hypotension (MeSH: D007022), run by General Hospital of Ningxia Medical University.
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 4 inclusion and 3 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 26 Oct 2026. 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?
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 Yi Chen (86-951-674-3252, czzyxgp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED90 (time frame: 1-15 minutes after spinal anesthesia). 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 26 Oct 2026.