Adverse Effect Clinical Trial
Official title:
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
Verified date | June 2023 |
Source | General Hospital of Ningxia Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | June 16, 2023 |
Est. primary completion date | June 16, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Ningxia Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ED50 and ED90 | The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients | 1-15 minutes after spinal anesthesia | |
Secondary | The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-15 minutes after spinal anesthesia | |
Secondary | The incidence of severe post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 60% of the baseline | 1-15 minutes after spinal anesthesia | |
Secondary | The incidence of bradycardia | Heart rate < 60 beats/min | 1-15 minutes after spinal anesthesia | |
Secondary | The incidence of nausea and vomiting | Presence of nausea and vomiting in patients after spinal anesthesia | 1-15 minutes after spinal anesthesia | |
Secondary | The incidence of hypertension | Systolic blood pressure (SBP) >120% of the baseline | 1-15 minutes after spinal anesthesia | |
Secondary | pH | From umbilical arterial blood gases | Immediately after delivery | |
Secondary | Partial pressure of oxygen (PO2) | From umbilical arterial blood gases | Immediately after delivery | |
Secondary | Base excess (BE) | From umbilical arterial blood gases | Immediately after delivery | |
Secondary | APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 1 minute after delivery | |
Secondary | APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5 minute after delivery |
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