Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

Xuzhou Medical University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications

Treatments: Drug: Norepinephrine; Drug: Phenylephrine; Drug: metaraminol

Study type: Interventional

Funder types: Other

Identifiers

NCT04991662

SFY2021-HZ08-11

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 78 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups

metaraminol group

Experimental group

Description:

During the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension.

Treatment:

Drug: metaraminol

phenylephrine group

Experimental group

Description:

During cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension.

Treatment:

Drug: Phenylephrine

norepinephrine group

Experimental group

Description:

During cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension.

Treatment:

Drug: Norepinephrine