OutcomeNCT06508359
Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension.
A study testing Norepinephrine and Phenylephrine in people with Outcome, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Outcome
- 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
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 21 Apr 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥37 weeks
- American Society of Anesthesiologists physical status classification II
- Scheduled for cesarean section under spinal anesthesia
Who cannot join
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluster Trial
This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.
Read the detailed description
Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2*2 crossover and cluster randomized trial.
- Conditions
- Outcome
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- Spinal anesthesia-induced hypotension, Norepinephrine, Phenylephrine, Neonatal outcomes, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Vasopressor
Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension
PhenylephrineDrug
Also called Vasopressor
Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic norepinephrine group | Experimental | A maintenance dose of norepinephrine (0.05 ug/kg/min) infusion simultaneous with spinal anesthesia. 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 |
| Prophylactic phenylephrine group | Experimental | A maintenance dose of phenylephrine (0.625 ug/kg/min) infusion simultaneous with spinal anesthesia. 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 |
| Rescue norepinephrine group | Active comparator | The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Spinal anesthesia-induced hypotension is managed by administering a 6 μg intravenous bolus of norepinephrine. Receives: Drug: Norepinephrine |
| Rescue phenylephrine group | Active comparator | The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Spinal anesthesia-induced hypotension is managed by administering a 75 μg intravenous bolus of phenylephrine. Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH
From umbilical arterial blood gases.
Measured: Immediately after delivery
Base excess (BE)
From umbilical arterial blood gases.
Measured: Immediately after delivery
Secondary outcomes (8)
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
The incidence of bradycardia
Heart rate < 60 beats/min
Measured: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting
Presence of nausea and vomiting in patients after spinal anesthesia
Measured: 1-15 minutes after spinal anesthesia
The incidence of hypertension
Systolic blood pressure (SBP) >120% of the baseline.
Measured: 1-15 minutes after spinal anesthesia
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases.
Measured: Immediately after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 1 min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 5 min after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Aug 2025
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomeStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Chen, M.D., Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508359
- Sponsor's protocol ID
- Yi Chen-2025-1
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluster Trial
- ClinicalTrials.gov ID
- NCT06508359
- Acronym / sponsor ID
- Yi Chen-2025-1
- Conditions
- Outcome
- Keywords
- Spinal anesthesia-induced hypotension, Norepinephrine, Phenylephrine, Neonatal outcomes, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 18 Jul 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.
This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.
Detailed description
Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2*2 crossover and cluster randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prophylactic norepinephrine group | Experimental | Drug: NorepinephrineA maintenance dose of norepinephrine (0.05 ug/kg/min) infusion simultaneous with spinal anesthesia. The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. |
| Prophylactic phenylephrine group | Experimental | Drug: PhenylephrineA maintenance dose of phenylephrine (0.625 ug/kg/min) infusion simultaneous with spinal anesthesia. The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. |
| Rescue norepinephrine group | Active comparator | 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. Spinal anesthesia-induced hypotension is managed by administering a 6 μg intravenous bolus of norepinephrine. |
| Rescue phenylephrine group | Active comparator | 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. Spinal anesthesia-induced hypotension is managed by administering a 75 μg intravenous bolus of phenylephrine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥37 weeks
- American Society of Anesthesiologists physical status classification II
- Scheduled for cesarean section under spinal anesthesia
Key exclusion criteria (5 listed)
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
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 |
|---|---|---|
| NorepinephrineAlso: VasopressorProphylactic or rescue norepinephrine for spinal anesthesia-induced hypotension | Drug | Prophylactic norepinephrine group, Rescue norepinephrine group |
| PhenylephrineAlso: VasopressorProphylactic or rescue phenylephrine for spinal anesthesia-induced hypotension | Drug | Prophylactic phenylephrine group, Rescue phenylephrine group |
Primary outcome
pH
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Base excess (BE)
Time frame: Immediately after delivery
From umbilical arterial blood gases.
8 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
The incidence of bradycardia
Time frame: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension
Time frame: 1-15 minutes after spinal anesthesia
Partial pressure of oxygen (PO2)
Time frame: Immediately after delivery
APGAR score
Time frame: 1 min after delivery
APGAR score
Time frame: 5 min after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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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.
Yi Chen, M.D. study chair
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Phenylephrine in people with Outcome, run by General Hospital of Ningxia Medical University at 1 site in China.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH (time frame: Immediately after delivery). The study lists 2 primary outcomes in all. 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 28 Apr 2026.