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Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

NCT ID: NCT04576663

Last Updated: 2021-11-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-09-21

Brief Summary

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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

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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. 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

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Adverse Effect

Keywords

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Phenylephrine Postspinal anesthesia hypotension Preeclampsia Cesarean section Dose-finding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

Normal saline infusion simultaneous with subarachnoid block

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline infusion simultaneous with subarachnoid block

0.3125 μg/kg/min group

A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Different infusion dose of phenylephrine simultaneous with subarachnoid block

0.625 μg/kg/min group

A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Different infusion dose of phenylephrine simultaneous with subarachnoid block

0.9375 μg/kg/min group

A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Different infusion dose of phenylephrine simultaneous with subarachnoid block

Interventions

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Normal saline

Normal saline infusion simultaneous with subarachnoid block

Intervention Type DRUG

Phenylephrine

Different infusion dose of phenylephrine simultaneous with subarachnoid block

Intervention Type DRUG

Other Intervention Names

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NS 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

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xinli Ni, Dr.

Role: STUDY_CHAIR

Hospital of Ningxia Medical University

Central Contacts

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Xinli Ni, Dr.

Role: CONTACT

Phone: 86-951-674-3252

Email: [email protected]

Yi Chen, M.D.

Role: CONTACT

Phone: 86-951-674-3252

Email: [email protected]

Other Identifiers

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Yi Chen-2020-6

Identifier Type: -

Identifier Source: org_study_id