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Clinical trial

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial

ID
Name
Yi Chen-2020-5
Description
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.
Trial arms
Trial start
2021-11-16
Estimated PCD
2023-06-06
Trial end
2023-06-06
Status
Completed
Treatment
Normal saline
Normal saline infusion simultaneous with subarachnoid block
Arms:
Control group
Other names:
NS
Norepinephrine
Different infusion dose of norepinephrine simultaneous with subarachnoid block
Arms:
0.025 μg/kg/min group, 0.050 μg/kg/min group, 0.075 μg/kg/min group
Other names:
Vasopressors
Size
180
Primary endpoint
The incidence of post-spinal anesthesia hypotension
1-15 minutes after spinal anesthesia.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2023-06-13

1 organization

1 product

1 drug

1 indication

Organization
General Hospital of Ningxia Medical University
Drug
Varlilumab
Indication
Adverse Effect
Product
Norepinephrine