Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

Xuzhou Medical University78 enrolled

Overview

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.

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Cesarean Section Complications

Interventions

metaraminolDRUG

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

PhenylephrineDRUG

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

NorepinephrineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Umbilical artery blood pH

pH value of fetal umbilical artery blood

Time frame: 30 seconds after delivery

Secondary Outcomes

hypotension

Number of Participants with systolic blood pressure reduction \>20% baseline value or systolic blood pressure \<90 mm Hg before delivery

Time frame: Intraoperative

bradycardia

Number of Participants with heart rate was ≤50 bpm before delivery

Time frame: Intraoperative

The incidence of nausea in pregnant women

Anesthesiologist observes combined patient dictation.

Time frame: Intraoperative

Umbilical artery blood base excess

base excess of fetal umbilical artery blood

Time frame: 30sec after delivery

The incidence of vomiting in pregnant women

Anesthesiologist observes combined patient dictation

Time frame: Intraoperative

Data from ClinicalTrials.gov

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