Cesarean Section Complications
Conditions
Brief summary
For hypotension after spinal anesthesia, metaraminol has different 90% effective doses in the supine position and the left-tilt position. We plan to conduct a non-inferiority trial to compare the effects of the two on the fetus and the mother.
Interventions
DRUGMetaraminol 2.7μg/kg/min
After spinal anesthesia, the patient was placed in a supine position until the fetus was delivered, and metaraminol was given at an initial rate of 2.7μg/kg/min throughout the process.
DRUGMetaraminol 2μg/kg/min
After spinal anesthesia, the patient was placed in left-tilt position until the fetus was delivered, and metaraminol was given at an initial rate of 2μg/kg/min throughout the process.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery; 2. height 150-180 cm; 3. American Society of Anesthesiologists (ASA) physical status II-III; 4. body mass index (BMI) \<35 kg/m2.
Exclusion criteria
1. transverse presentation, fetal macrosomia; 2. uterine abnormalities (eg, large fibroids, bicornuate uterus); 3. polyhydramnios; 4. ruptured membranes, oligohydramnios; 5. intrauterine growth restriction; 6. gestational or nongestational hypertension, diabetes, or eclampsia; 7. hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure; 8. contraindications for combined spinal-epidural anesthesia; 9. participants who declined to sign informed consent forms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical artery blood pH | 30 seconds after delivery | pH value of fetal umbilical artery blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hypotension | Intraoperative | Number of Participants with systolic blood pressure reduction \>20% baseline value or systolic blood pressure \<90 mm Hg before delivery |
| bradycardia | Intraoperative | Number of Participants with heart rate was ≤50 bpm before delivery Number of Participants with heart rate was ≤50 bpm before delivery Number of Participants with heart rate was ≤50 bpm before delivery |
| The incidence of nausea in pregnant women | Intraoperative | Anesthesiologist observes combined patient dictation. |
| Umbilical artery blood base excess | 30sec after delivery | base excess of fetal umbilical artery blood |
| The incidence of vomiting in pregnant women | Intraoperative | Anesthesiologist observes combined patient dictation |
Countries
China
Outcome results
None listed