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Adverse EffectNCT04556370

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.

A study testing Normal saline and Norepinephrine in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the suitable infusion dose of norepinephrine 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 Norepinephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
16 Nov 2021to 6 Jun 2023
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.

China1 site

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 75004

Other trials in China

About this study

Official title: Norepinephrine 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 norepinephrine 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. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Conditions
Adverse Effect
Being tested
Normal saline, Norepinephrine
Keywords
Norepinephrine, 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

  • NorepinephrineDrug

    Also called Vasopressors

    Different infusion dose of norepinephrine simultaneous with subarachnoid block

Study groups in NCT04556370
Study groupRoleWhat they receive
Control groupPlacebo comparatorNormal saline infusion simultaneous with subarachnoid block
Receives: Drug: Normal saline
0.025 μg/kg/min groupExperimentalA maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block
Receives: Drug: Norepinephrine
0.050 μg/kg/min groupExperimentalA maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block
Receives: Drug: Norepinephrine
0.075 μg/kg/min groupExperimentalA maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block
Receives: Drug: Norepinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. Overall stability of systolic blood pressure control versus baseline

    Evaluated by performance error (PE)

    Measured: 1-15 minutes after spinal anesthesia

  2. Overall stability of heart rate control versus baseline

    Evaluated by performance error (PE)

    Measured: 1-15 minutes after spinal anesthesia

  3. The incidence of severe post-spinal anesthesia hypotension

    Systolic blood pressure (SBP) < 60% of the baseline

    Measured: 1-15 minutes after spinal anesthesia

  4. The incidence of nausea and vomiting

    Presence of nausea and vomiting in patients after spinal anesthesia

    Measured: 1-15 minutes after spinal anesthesia

  5. The incidence of bradycardia

    Heart rate < 55 beats/min

    Measured: 1-15 minutes after spinal anesthesia

  6. The incidence of hypertension.

    Systolic blood pressure (SBP) >120% of the baseline.

    Measured: 1-15 minutes after spinal anesthesia

  7. pH

    From umbilical arterial blood gases.

    Measured: Immediately after delivery

  8. Partial pressure of oxygen

    From umbilical arterial blood gases.

    Measured: Immediately after delivery

  9. Base excess

    From umbilical arterial blood gases.

    Measured: Immediately after delivery

  10. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Measured: 1 min after delivery

  11. 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.

  1. First posted21 Sep 2020
  2. Study start16 Nov 2021
  3. Primary completion6 Jun 2023
  4. Study completion6 Jun 2023

Resources

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04556370
Sponsor's protocol ID
Yi Chen-2020-5
Status last verified
Jun 2023
First submitted
15 Sep 2020
Last updated
13 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen Y, Guo L, Qin R, Xi N, Wang S, Ma Y, Ni X. Dose-Response Study of Norepinephrine Infusion for Maternal Hypotension in Preeclamptic Patients Undergoing Cesarean Delivery Under Spinal Anesthesia. Clin Pharmacokinet. 2024 Jun;63(6):847-856. doi: 10.1007/s40262-024-01381-4. Epub 2024 Jun 13.

    PubMed 38869701

Questions about this trial

What is this clinical trial studying?

A study testing Normal saline and Norepinephrine in people with Adverse Effect, 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 13 Jun 2023. 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. 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?

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?

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?

On the ClinicalTrials.gov record for NCT04556370, which also lists 1 linked publication.

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 13 Jun 2023.

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