Hemodynamic InstabilityNCT05035485
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
A study testing Phenylephrine and Norepinephrine in people with Hemodynamic Instability, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for 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
- Hemodynamic Instability
- What is being tested?
- Phenylephrine and Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 21 Jan 2024
- 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
1 site in 1 country.
About this study
Official title: Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses During Spinal Anesthesia for Caesarean Section in Patients With Severe Preeclampsia: a Randomized, Controlled Trial
The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for 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. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. However, hemodynamic effects of the rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
- Conditions
- Hemodynamic Instability
- Being tested
- Phenylephrine, Norepinephrine
- Keywords
- Cardiac output response, Norepinephrine, Phenylephrine, Preeclampsia, Cesarean section
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Vasopressors
A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
NorepinephrineDrug
Also called Vasopressors
A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine group | Active comparator | Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred Receives: Drug: Phenylephrine |
| Norepinephrine group | Experimental | Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output (CO)
Evaluated by the VIGILCO monitoring system.
Measured: 1-30 minutes after spinal anesthesia.
Stroke volume (SV)
Evaluated by the VIGILCO monitoring system.
Measured: 1-30 minutes after spinal anesthesia
Systemic vascular resistance (SVR)
Evaluated by the VIGILCO monitoring system.
Measured: 1-30 minutes after spinal anesthesia
Secondary outcomes (12)
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE)
Measured: 1-30 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline
Evaluated by performance error (PE)
Measured: 1-30 minutes after spinal anesthesia
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
Measured: 1-30 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) < 60% of the baseline
Measured: 1-30 minutes after spinal anesthesia.
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Measured: 1-30 minutes after spinal anesthesia
The incidence of bradycardia.
Heart rate < 60 beats/min.
Measured: 1-30 minutes after spinal anesthesia
The incidence of hypertension.
Systolic blood pressure (SBP) >120% of the baseline.
Measured: 1-30 minutes after spinal anesthesia
pH
From umbilical arterial blood gases.
Measured: Immediately after delivery
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases.
Measured: Immediately after delivery
Base excess (BE)
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 posted5 Sep 2021
- Study start13 Sep 2022
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 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 UniversityXiangzhao Xu, M.D.; Ph. D, Study chair, The People's Hospital of Nanchuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035485
- Sponsor's protocol ID
- Yi Chen-2021-2
- Status last verified
- Jan 2024
- First submitted
- 2 Sep 2021
- Last updated
- 2 Feb 2024
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses During Spinal Anesthesia for Caesarean Section in Patients With Severe Preeclampsia: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05035485
- Acronym / sponsor ID
- Yi Chen-2021-2
- Conditions
- Hemodynamic Instability
- Keywords
- Cardiac output response, Norepinephrine, Phenylephrine, Preeclampsia, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 5 Sep 2021 (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 maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for 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. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. However, hemodynamic effects of the rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine group | Active comparator | Drug: PhenylephrineRescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred |
| Norepinephrine group | Experimental | Drug: NorepinephrineRescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred |
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 |
|---|---|---|
| PhenylephrineAlso: VasopressorsA rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia | Drug | Phenylephrine group |
| NorepinephrineAlso: VasopressorsA rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia | Drug | Norepinephrine group |
Primary outcome
Cardiac output (CO)
Time frame: 1-30 minutes after spinal anesthesia.
Evaluated by the VIGILCO monitoring system.
Stroke volume (SV)
Time frame: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system.
Systemic vascular resistance (SVR)
Time frame: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system.
12 secondary outcomes
Overall stability of systolic blood pressure control versus baseline
Time frame: 1-30 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline
Time frame: 1-30 minutes after spinal anesthesia
The incidence of post-spinal anesthesia hypotension
Time frame: 1-30 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension.
Time frame: 1-30 minutes after spinal anesthesia.
The incidence of nausea and vomiting.
Time frame: 1-30 minutes after spinal anesthesia
The incidence of bradycardia.
Time frame: 1-30 minutes after spinal anesthesia
The incidence of hypertension.
Time frame: 1-30 minutes after spinal anesthesia
pH
Time frame: Immediately after delivery
Partial pressure of oxygen (PO2)
Time frame: Immediately after delivery
Base excess (BE)
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 2 Feb 2024.
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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
Xiangzhao Xu, M.D.; Ph. D study chair
The People's Hospital of Nanchuan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine and Norepinephrine in people with Hemodynamic Instability, 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 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: finished, as of the sponsor's last update on 2 Feb 2024. 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?
Cardiac output (CO) (time frame: 1-30 minutes after spinal anesthesia.). The study lists 3 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 2 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.