Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section：A Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05084599
• Other study ID #: 2021PHB455-001
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For hypotension after spinal anesthesia, metaraminol has different 90% effective doses in the supine position and the left-tilt position. We plan to conduct a non-inferiority trial to compare the effects of the two on the fetus and the mother.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• 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 2.7µg/kg/min
After spinal anesthesia, the patient was placed in a supine position until the fetus was delivered, and metaraminol was given at an initial rate of 2.7µg/kg/min throughout the process.
• Metaraminol 2µg/kg/min
After spinal anesthesia, the patient was placed in left-tilt position until the fetus was delivered, and metaraminol was given at an initial rate of 2µg/kg/min throughout the process.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

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