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Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

Effect of Three Weight-adjusted Vasopressors for With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04991662
Enrollment
78
Registered
2021-08-05
Start date
2021-10-10
Completion date
2021-12-03
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Brief summary

This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.

Detailed description

At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .

Interventions

Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

DRUGPhenylephrine

Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

DRUGNorepinephrine

Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Umbilical artery blood pH30 seconds after deliverypH value of fetal umbilical artery blood

Secondary

MeasureTime frameDescription
hypotensionIntraoperativeNumber of Participants with systolic blood pressure reduction \>20% baseline value or systolic blood pressure \<90 mm Hg before delivery
bradycardiaIntraoperativeNumber of Participants with heart rate was ≤50 bpm before delivery
The incidence of nausea in pregnant womenIntraoperativeAnesthesiologist observes combined patient dictation.
Umbilical artery blood base excess30sec after deliverybase excess of fetal umbilical artery blood
The incidence of vomiting in pregnant womenIntraoperativeAnesthesiologist observes combined patient dictation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026