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Clinical trial

90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment During Cesarean Section

ID
Name
Yi Chen-2024-4
Description
The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section
Trial arms
Trial start
2025-04-01
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Not yet recruiting
Treatment
Alpha-Agonist
An initial infusion dose of prophylactic phenylephrine (0.625 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.125 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Standard group
Other names:
norepinephrine
α-adrenergic receptor agonist
An initial infusion dose of prophylactic phenylephrine (0.625 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.125 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Intensive group
Other names:
norepinephrine
Size
80
Primary endpoint
ED50 and ED90
1-15 minutes after spinal anesthesia
Eligibility criteria
Inclusion Criteria: * 18-45 years * Primipara or multipara * Singleton pregnancy ≥37 weeks * American Society of Anesthesiologists physical status classification I to II * Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: * Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg * Hemoglobin \< 7g/dl
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-11-30

1 organization

2 products

1 indication

Organization
General Hospital of Ningxia Medical University
Product
Alpha-Agonist
Indication
Adverse Effect
Product
α-adrenergic receptor agonist