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Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia

G

General Hospital of Ningxia Medical University

Status

Completed

Conditions

Hemodynamic Instability

Treatments

Drug: Phenylephrine
Drug: Norepinephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT05035485
Yi Chen-2021-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Phenylephrine group
Active Comparator group
Description:
Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred
Treatment:
Drug: Phenylephrine
Norepinephrine group
Experimental group
Description:
Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred
Treatment:
Drug: Norepinephrine

Trial contacts and locations

1

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Central trial contact

Yi Chen, M.D.; Xiangzhao Xu, M.D.; Ph. D

Data sourced from clinicaltrials.gov

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