Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

Phase 4

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine; Drug: metaraminol

• Registration Number: NCT04991662
• Lead Sponsor: Xuzhou Medical University

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 .

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-05
• Status Verified: 2021-09
• Study Start: 2021-10-10
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phenylephrine group	Phenylephrine	During cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension.
norepinephrine group	Norepinephrine	During cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension.
metaraminol group	metaraminol	During the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension.

Primary Outcome Measures

Name	Time	Method
Umbilical artery blood pH	30 seconds after delivery	pH value of fetal umbilical artery blood

Secondary Outcome Measures

Name	Time	Method
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
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
The incidence of nausea in pregnant women	Intraoperative	Anesthesiologist observes combined patient dictation.

Trial Locations

Locations (1)

Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital; 🇨🇳 Peking, Beijing, China