Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

ED90 of Norepinephrine and Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive Treatment in Preeclamptic Patients During Cesarean Section

ID
Name
Yi Chen-2024-11
Description
The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section
Trial arms
Trial start
2025-01-01
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Not yet recruiting
Treatment
Norepinephrine
An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Norepinephrine group
Other names:
Vasopressor
Phenylephrine
An initial infusion dose of prophylactic phenylephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Phenylephrine group
Other names:
Vasopressor
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 ≥32 weeks * American Society of Anesthesiologists physical status classification I to III * Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: * Baseline blood pressure ≥160 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-12-06

1 organization

2 products

1 indication

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