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

Phase 4

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: Metaraminol 2μg/kg/min; Drug: Metaraminol 2.7μg/kg/min

• Registration Number: NCT05084599
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Study Start: 2022-05-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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
left-tilt group	Metaraminol 2μg/kg/min	After spinal anesthesia, the patient was placed in a 15° left position until the fetus was delivered, and metaraminol was given at an initial rate of 2.00μg/kg/min throughout the process.
supine group	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.

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
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 Number of Participants with heart rate was ≤50 bpm before delivery Number of Participants with heart rate was ≤50 bpm before delivery
The incidence of vomiting in pregnant women	Intraoperative	Anesthesiologist observes combined patient dictation
Umbilical artery blood base excess	30sec after delivery	base excess of fetal umbilical artery blood
The incidence of nausea in pregnant women	Intraoperative	Anesthesiologist observes combined patient dictation.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China