Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2023-06-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

NCT04556357

Adverse Effect

COMPLETED NA

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

NCT04272567

Adverse Effect

COMPLETED NA

Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

NCT04576663

Adverse Effect

UNKNOWN NA

The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

NCT05035472

Adverse Effect

UNKNOWN NA

Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia

NCT05035498

Hemodynamic Instability

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

0.025 μg/kg/min group

A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Different infusion dose of norepinephrine simultaneous with subarachnoid block

0.050 μg/kg/min group

A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Different infusion dose of norepinephrine simultaneous with subarachnoid block

0.075 μg/kg/min group

A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Different infusion dose of norepinephrine simultaneous with subarachnoid block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normal saline

Normal saline infusion simultaneous with subarachnoid block

Intervention Type DRUG

Norepinephrine

Different infusion dose of norepinephrine simultaneous with subarachnoid block

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NS Vasopressors

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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