Hypotension After Spinal AnesthesiaPhase 4NCT07824713
ED50/ED90 of Phenylephrine Infusion for Preventing Spinal Anesthesia-Induced Hypotension: Supine vs Left-Tilt 15°
A Phase 4 study testing Phenylephrine hydrochloride infusion in people with Hypotension After Spinal Anesthesia, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the 50% and 90% effective doses (ED50 and ED90) of prophylactic phenylephrine infusion for preventing spinal anesthesia-induced hypotension during elective cesarean delivery, in the supine position and in the left-lateral-tilt 15° position, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension After Spinal Anesthesia
- What is being tested?
- Phenylephrine hydrochloride infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 31 Jan 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton term pregnancy scheduled for elective cesarean delivery
- Height 150-180 cm
- ASA physical status II-III
- Body mass index < 35 kg/m2
Who cannot join
- Transverse lie or suspected macrosomia
- Uterine abnormalities (e.g., large uterine fibroids, bicornuate uterus)
- Polyhydramnios
- Ruptured membranes or oligohydramnios
- Fetal growth restriction
- Gestational or pregestational hypertension, diabetes mellitus, or preeclampsia
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- Diseases associated with autonomic neuropathy (e.g., diabetes mellitus > 10 years) or renal failure
- Contraindications to spinal anesthesia
- Refusal to provide written informed consent-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Anesthesiology，Xuzhou HeJia Hospital, Xuzhou, Jiangsu, China
Xuzhou, Jiangsu, 221000
About this study
Official title: Determination of the ED50 and ED90 of Prophylactic Phenylephrine Infusion for the Prevention of Spinal Anesthesia-Induced Hypotension During Elective Cesarean Delivery in the Supine and Left-Lateral-Tilt 15° Positions: A Randomized, Concentration-Blinded, Parallel-Group Dose-Response Study
The purpose of this study is to determine the 50% and 90% effective doses (ED50 and ED90) of prophylactic phenylephrine infusion for preventing spinal anesthesia-induced hypotension during elective cesarean delivery, in the supine position and in the left-lateral-tilt 15° position, respectively. Two hundred parturients with singleton term pregnancies will be randomized 1:1 to the supine group or the left-tilt 15° group, and within each position 1:1:1:1 to one of four fixed phenylephrine infusion rates (0.2, 0.4, 0.6, or 0.8 μg/kg/min; 25 per group), with the rate allocation masked by concentration blinding (identical pump rate, different solution concentrations). Spinal anesthesia consists of hyperbaric bupivacaine 12 mg plus morphine 0.15 mg. The primary outcome is the incidence of hypotension (systolic blood pressure < 80% of baseline or < 90 mmHg) from completion of the intrathecal injection to delivery. ED50 and ED90 will be estimated by probit regression within each position.
- Conditions
- Hypotension After Spinal Anesthesia
- Being tested
- Phenylephrine hydrochloride infusion
- Keywords
- Hypotension, Cesarean Delivery, Phenylephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine hydrochloride infusionDrug
Prophylactic fixed-rate IV infusion (pump rate 0.6 mL/kg/h, concentration-blinded), from completion of spinal anesthesia until delivery
| Study group | Role | What they receive |
|---|---|---|
| Supine Position - Phenylephrine 0.2 μg/kg/min | Experimental | Participants in the supine position (maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg/kg/min (pump rate 0.6 mL/kg/h, concentration-blinded solution 20 μg/mL) from completion of spinal anesthesia until delivery. Receives: Drug: Phenylephrine hydrochloride infusion |
| Supine Position - Phenylephrine 0.4 μg/kg/min | Experimental | Supine position as Arm 1; phenylephrine infusion 0.4 μg/kg/min (concentration-blinded solution 40 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
| Supine Position - Phenylephrine 0.6 μg/kg/min | Experimental | Supine position as Arm 1; phenylephrine infusion 0.6 μg/kg/min (concentration-blinded solution 60 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
| Supine Position - Phenylephrine 0.8 μg/kg/min | Experimental | Supine position as Arm 1; phenylephrine infusion 0.8 μg/kg/min (concentration-blinded solution 80 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
| Left-Tilt 15° - Phenylephrine 0.2 μg/kg/min | Active comparator | Participants in the left-lateral-tilt 15° position (sponge wedge 7.5 × 28 × 50 cm under the thoracolumbar region, maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg/kg/min (pump rate 0.6 mL/kg/h, concentration-blinded solution 20 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
| Left-Tilt 15° - Phenylephrine 0.4 μg/kg/min | Experimental | Left-tilt 15° position as Arm 5; phenylephrine infusion 0.4 μg/kg/min (concentration-blinded solution 40 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
| Left-Tilt 15° - Phenylephrine 0.6 μg/kg/min | Active comparator | Left-tilt 15° position as Arm 5; phenylephrine infusion 0.6 μg/kg/min (concentration-blinded solution 60 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
| Left-Tilt 15° - Phenylephrine 0.8 μg/kg/min | Active comparator | Left-tilt 15° position as Arm 5; phenylephrine infusion 0.8 μg/kg/min (concentration-blinded solution 80 μg/mL). Receives: Drug: Phenylephrine hydrochloride infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotension incidence of hypotension from completion of intrathecal injection to delivery of the infant
Hypotension defined as systolic blood pressure < 80% of baseline (measured in the assigned study position) or < 90 mmHg
Measured: From completion of spinal anesthesia to fetal delivery
Secondary outcomes (5)
Umbilical artery and umbilical vein blood gas values
Umbilical artery and umbilical vein blood gas values (pH, PCO2, PO2, base excess, lactate)
Measured: At delivery
Apgar scores at 1 and 5 minutes after delivery
Measured: From fetal delivery to 5 minutes after delivery
Time to first rescue vasopressor
Measured: From completion of intrathecal injection to delivery
Serial systolic blood pressure values within 12 minutes after intrathecal injection
Measured: From completion of spinal anesthesia to 12 minutes after completion of spinal anesthesia
Incidence of hypertension before delivery
Incidence of hypertension (systolic blood pressure ≥ 120% of baseline) before delivery
Measured: From completion of intrathecal injection to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start20 Sep 2026 (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 Hypotension After Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- XuZhouHeJia hospital
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824713
- Sponsor's protocol ID
- hjyy-1-2026-01
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the ED50 and ED90 of Prophylactic Phenylephrine Infusion for the Prevention of Spinal Anesthesia-Induced Hypotension During Elective Cesarean Delivery in the Supine and Left-Lateral-Tilt 15° Positions: A Randomized, Concentration-Blinded, Parallel-Group Dose-Response Study
- ClinicalTrials.gov ID
- NCT07824713
- Acronym / sponsor ID
- hjyy-1-2026-01
- Conditions
- Hypotension After Spinal Anesthesia
- Keywords
- Hypotension, Cesarean Delivery, Phenylephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- XuZhouHeJia hospital
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Sep 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.
The purpose of this study is to determine the 50% and 90% effective doses (ED50 and ED90) of prophylactic phenylephrine infusion for preventing spinal anesthesia-induced hypotension during elective cesarean delivery, in the supine position and in the left-lateral-tilt 15° position, respectively. Two hundred parturients with singleton term pregnancies will be randomized 1:1 to the supine group or the left-tilt 15° group, and within each position 1:1:1:1 to one of four fixed phenylephrine infusion rates (0.2, 0.4, 0.6, or 0.8 μg/kg/min; 25 per group), with the rate allocation masked by concentration blinding (identical pump rate, different solution concentrations). Spinal anesthesia consists of hyperbaric bupivacaine 12 mg plus morphine 0.15 mg. The primary outcome is the incidence of hypotension (systolic blood pressure < 80% of baseline or < 90 mmHg) from completion of the intrathecal injection to delivery. ED50 and ED90 will be estimated by probit regression within each position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Supine Position - Phenylephrine 0.2 μg/kg/min | Experimental | Drug: Phenylephrine hydrochloride infusionParticipants in the supine position (maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg/kg/min (pump rate 0.6 mL/kg/h, concentration-blinded solution 20 μg/mL) from completion of spinal anesthesia until delivery. |
| Supine Position - Phenylephrine 0.4 μg/kg/min | Experimental | Drug: Phenylephrine hydrochloride infusionSupine position as Arm 1; phenylephrine infusion 0.4 μg/kg/min (concentration-blinded solution 40 μg/mL). |
| Supine Position - Phenylephrine 0.6 μg/kg/min | Experimental | Drug: Phenylephrine hydrochloride infusionSupine position as Arm 1; phenylephrine infusion 0.6 μg/kg/min (concentration-blinded solution 60 μg/mL). |
| Supine Position - Phenylephrine 0.8 μg/kg/min | Experimental | Drug: Phenylephrine hydrochloride infusionSupine position as Arm 1; phenylephrine infusion 0.8 μg/kg/min (concentration-blinded solution 80 μg/mL). |
| Left-Tilt 15° - Phenylephrine 0.2 μg/kg/min | Active comparator | Drug: Phenylephrine hydrochloride infusionParticipants in the left-lateral-tilt 15° position (sponge wedge 7.5 × 28 × 50 cm under the thoracolumbar region, maintained from completion of spinal anesthesia until delivery) receiving prophylactic phenylephrine infusion 0.2 μg/kg/min (pump rate 0.6 mL/kg/h, concentration-blinded solution 20 μg/mL). |
| Left-Tilt 15° - Phenylephrine 0.4 μg/kg/min | Experimental | Drug: Phenylephrine hydrochloride infusionLeft-tilt 15° position as Arm 5; phenylephrine infusion 0.4 μg/kg/min (concentration-blinded solution 40 μg/mL). |
| Left-Tilt 15° - Phenylephrine 0.6 μg/kg/min | Active comparator | Drug: Phenylephrine hydrochloride infusionLeft-tilt 15° position as Arm 5; phenylephrine infusion 0.6 μg/kg/min (concentration-blinded solution 60 μg/mL). |
| Left-Tilt 15° - Phenylephrine 0.8 μg/kg/min | Active comparator | Drug: Phenylephrine hydrochloride infusionLeft-tilt 15° position as Arm 5; phenylephrine infusion 0.8 μg/kg/min (concentration-blinded solution 80 μg/mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton term pregnancy scheduled for elective cesarean delivery
- Height 150-180 cm
- ASA physical status II-III
- Body mass index < 35 kg/m2
Key exclusion criteria (9 listed)
- Transverse lie or suspected macrosomia
- Uterine abnormalities (e.g., large uterine fibroids, bicornuate uterus)
- Polyhydramnios
- Ruptured membranes or oligohydramnios
- Fetal growth restriction
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 |
|---|---|---|
| Phenylephrine hydrochloride infusionProphylactic fixed-rate IV infusion (pump rate 0.6 mL/kg/h, concentration-blinded), from completion of spinal anesthesia until delivery | Drug | Left-Tilt 15° - Phenylephrine 0.2 μg/kg/min, Left-Tilt 15° - Phenylephrine 0.4 μg/kg/min, Left-Tilt 15° - Phenylephrine 0.6 μg/kg/min, Left-Tilt 15° - Phenylephrine 0.8 μg/kg/min, Supine Position - Phenylephrine 0.2 μg/kg/min, Supine Position - Phenylephrine 0.4 μg/kg/min, Supine Position - Phenylephrine 0.6 μg/kg/min, Supine Position - Phenylephrine 0.8 μg/kg/min |
Primary outcome
hypotension incidence of hypotension from completion of intrathecal injection to delivery of the infant
Time frame: From completion of spinal anesthesia to fetal delivery
Hypotension defined as systolic blood pressure < 80% of baseline (measured in the assigned study position) or < 90 mmHg
5 secondary outcomes
Umbilical artery and umbilical vein blood gas values
Time frame: At delivery
Apgar scores at 1 and 5 minutes after delivery
Time frame: From fetal delivery to 5 minutes after delivery
Time to first rescue vasopressor
Time frame: From completion of intrathecal injection to delivery
Serial systolic blood pressure values within 12 minutes after intrathecal injection
Time frame: From completion of spinal anesthesia to 12 minutes after completion of spinal anesthesia
Incidence of hypertension before delivery
Time frame: From completion of intrathecal injection to 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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine hydrochloride infusion in people with Hypotension After Spinal Anesthesia, run by Peking University People's Hospital 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 4 inclusion and 9 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 17 Sep 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.
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 Feng Feng, Dr. (13601083503, doc_yifeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypotension incidence of hypotension from completion of intrathecal injection to delivery of the infant (time frame: From completion of spinal anesthesia to fetal delivery). 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 17 Sep 2026.