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Norepinephrine Bolus for Maternal Hypotension During Cesarean Section

NCT06498115Phase 4

Key facts

Status: Recruiting
Start: Jul 2024
Primary completion: Sep 2024
Countries: 1
Sponsor: Bengbu Third People's Hospital
Modality: Small Molecules

Drugs: norepinephrine
Conditions: hypotension

Overview

Phase 4, open-label, single-arm trial of norepinephrine in hypotension, sponsored by Bengbu Third People's Hospital. Primary endpoint: Intravenous norepinephrine dose to maintain maternal systolic blood pressure. Started Jul 2024; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

Norepinephrine Bolus
Participants receive norepinephrine bolus for hypotension; dose adjusted sequentially.

Who it enrols

Healthy women with singleton full-term pregnancies undergoing elective cesarean section under spinal anesthesia, ASA I-II, weight 50-100kg, height 150-180cm.

Endpoints

Primary

Intravenous norepinephrine dose to maintain maternal systolic blood pressureIntraoperative

Secondary

Intraoperative adverse reactionsPerioperative period
Number of remedial drugsPerioperative period
Neonatal Apgar scoreImmediately after delivery

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