Clinical trial
90% Effective Dose of Norepinephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment During Cesarean Section
Name
Yi Chen-2024-3
Description
The objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section
Trial arms
Trial start
2025-01-01
Estimated PCD
2025-03-31
Trial end
2025-03-31
Status
Not yet recruiting
Treatment
Alpha-Agonist
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:
Standard group
Other names:
norepinephrine
α-adrenergic receptor agonist
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:
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
* 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
2023-11-30
1 organization
2 products
1 indication
Organization
General Hospital of Ningxia Medical UniversityProduct
Alpha-AgonistIndication
Adverse Effect