Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991662
• Other study ID #: SFY2021-HZ08-11
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2021
• Est. completion date: December 3, 2021

Study information

• Verified date: September 2021
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• metaraminol
Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
• Phenylephrine
Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
• Norepinephrine
Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Locations

Country	Name	City	State
China	Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical artery blood pH	pH value of fetal umbilical artery blood	30 seconds after delivery
Secondary	hypotension	Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery	Intraoperative
Secondary	bradycardia	Number of Participants with heart rate was =50 bpm before delivery	Intraoperative
Secondary	The incidence of nausea in pregnant women	Anesthesiologist observes combined patient dictation.	Intraoperative
Secondary	Umbilical artery blood base excess	base excess of fetal umbilical artery blood	30sec after delivery
Secondary	The incidence of vomiting in pregnant women	Anesthesiologist observes combined patient dictation	Intraoperative