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Clinical trial

Up-and-Down Determination of Different Crystalloid Coload Volumes on the 90% Effective Dose of Prophylactic Norepinephrine Infusions for Preventing Postspinal Anesthesia Hypotension During Cesarean Section

ID
Name
Yi Chen-2023-2
Description
The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during cesarean section.
Trial arms
Trial start
2023-03-21
Estimated PCD
2023-06-16
Trial end
2023-06-16
Status
Completed
Treatment
Crystalloid - 0 ml/kg
No fluid coload was given. An initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Control group
Other names:
Crystalloid
Crystalloid - 5 ml/kg
5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Crystalloid - 5 ml/kg
Other names:
Crystalloid
Crystalloid - 10 ml/kg
10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Arms:
Crystalloid - 10 ml/kg
Other names:
Crystalloid
Size
90
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', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2023-06-22

1 organization

1 product

1 indication

Organization
General Hospital of Ningxia Medical University
Product
Crystalloid
Indication
Adverse Effect