Adverse EffectNCT04576663
Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
A study testing Normal saline and Phenylephrine in people with Adverse Effect, run by General Hospital of Ningxia Medical University.
Trial summary
The purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Adverse Effect
- What is being tested?
- Normal saline and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 21 Sep 2025
- 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 ≥32 weeks
- American Society of Anesthesiologists physical status classification II to III
- Scheduled for cesarean section under spinal anesthesia
Who cannot join
- Baseline blood pressure ≥180 mmHg
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
The purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Read the detailed description
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. Practical guidelines for obstetric anesthesia from the American Society of Anesthesiologists and an international consensus statement on the management of hypotension with vasopressors indicate either IV ephedrine or phenylephrine may be used to correct hypotension. But the suitable infusion dose of phenylephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
- Conditions
- Adverse Effect
- Being tested
- Normal saline, Phenylephrine
- Keywords
- Phenylephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section, Dose-finding
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called NS
Normal saline infusion simultaneous with subarachnoid block
PhenylephrineDrug
Also called Vasopressors
Different infusion dose of phenylephrine simultaneous with subarachnoid block
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Normal saline infusion simultaneous with subarachnoid block Receives: Drug: Normal saline |
| 0.3125 μg/kg/min group | Experimental | A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block Receives: Drug: Phenylephrine |
| 0.625 μg/kg/min group | Experimental | A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block Receives: Drug: Phenylephrine |
| 0.9375 μg/kg/min group | Experimental | A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
Measured: 1-15 minutes after spinal anesthesia
Secondary outcomes (11)
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE)
Measured: 1-15 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline
Evaluated by performance error (PE)
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 nausea and vomiting
Presence of nausea and vomiting in patients after spinal anesthesia
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 hypertension.
Systolic blood pressure (SBP) >120% of the baseline.
Measured: 1-15 minutes after spinal anesthesia
pH
From umbilical arterial blood gases.
Measured: Immediately after delivery
Partial pressure of oxygen
From umbilical arterial blood gases.
Measured: Immediately after delivery
Base excess
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 posted6 Oct 2020
- Study start1 Oct 2023 (estimated)
- Primary completion21 Sep 2025 (estimated)
- Study completion21 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectStudies 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinli Ni, Dr., Study chair, Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576663
- Sponsor's protocol ID
- Yi Chen-2020-6
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2020
- Last updated
- 29 Nov 2021
- 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 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
- ClinicalTrials.gov ID
- NCT04576663
- Acronym / sponsor ID
- Yi Chen-2020-6
- Conditions
- Adverse Effect
- Keywords
- Phenylephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section, Dose-finding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 21 Sep 2025 (estimated)
- First posted
- 6 Oct 2020 (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 investigate the suitable infusion dose of phenylephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Detailed description
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. Practical guidelines for obstetric anesthesia from the American Society of Anesthesiologists and an international consensus statement on the management of hypotension with vasopressors indicate either IV ephedrine or phenylephrine may be used to correct hypotension. But the suitable infusion dose of phenylephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Normal salineNormal saline infusion simultaneous with subarachnoid block |
| 0.3125 μg/kg/min group | Experimental | Drug: PhenylephrineA maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block |
| 0.625 μg/kg/min group | Experimental | Drug: PhenylephrineA maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block |
| 0.9375 μg/kg/min group | Experimental | Drug: PhenylephrineA maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block |
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 ≥32 weeks
- American Society of Anesthesiologists physical status classification II to III
- Scheduled for cesarean section under spinal anesthesia
Key exclusion criteria (6 listed)
- Baseline blood pressure ≥180 mmHg
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension
- Hemoglobin < 7g/dl
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 |
|---|---|---|
| Normal salineAlso: NSNormal saline infusion simultaneous with subarachnoid block | Drug | Control group |
| PhenylephrineAlso: VasopressorsDifferent infusion dose of phenylephrine simultaneous with subarachnoid block | Drug | 0.3125 μg/kg/min group, 0.625 μg/kg/min group, 0.9375 μg/kg/min group |
Primary outcome
The incidence of post-spinal anesthesia hypotension
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
11 secondary outcomes
Overall stability of systolic blood pressure control versus baseline
Time frame: 1-15 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline
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 nausea and vomiting
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension.
Time frame: 1-15 minutes after spinal anesthesia
pH
Time frame: Immediately after delivery
Partial pressure of oxygen
Time frame: Immediately after delivery
Base excess
Time frame: Immediately after delivery
APGAR score
Time frame: 1 min after delivery
APGAR score
Time frame: 5 min after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
Related trials for Adverse Effect
Not yet recruiting
Effects of a Visual Interactive LINE Chatbot on Self-Management of EGFR-TKI Related Side Effects in Patients With Lung Cancer
Non-Small Cell Lung Cancer
Not yet recruiting
Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer
Advanced Colorectal Cancer, Capecitabine-Related Adverse Reaction
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Not yet recruitingObservational study
Antipsychotic Safety and Adherence in Patients With Psychiatric Disorders-An Egyptian Institution-Based Cross-Sectional Study.
Psychiatric Disorder
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.
Xinli Ni, Dr. study chair
Hospital of Ningxia Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and Phenylephrine in people with Adverse Effect, 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 5 inclusion and 6 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 29 Nov 2021. 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. Some participants in this study may receive a placebo. 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 Xinli Ni, Dr. (86-951-674-3252, xinlini6@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post-spinal anesthesia hypotension (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 29 Nov 2021.