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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2024-01-21

Brief Summary

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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.

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Detailed Description

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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

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Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Phenylephrine group

Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

Norepinephrine group

Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

Interventions

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Phenylephrine

A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

Intervention Type DRUG

Norepinephrine

A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

Intervention Type DRUG

Other Intervention Names

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Vasopressors Vasopressors

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No