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

Peking University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications

Treatments: Drug: Metaraminol 2.7μg/kg/min; Drug: Metaraminol 2μg/kg/min

Study type: Interventional

Funder types: Other

Identifiers

NCT05084599

2021PHB455-001

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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: None (Open label)

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124 participants in 2 patient groups, including a placebo group

left-tilt group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Metaraminol 2μg/kg/min

supine group

Experimental group

Description:

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.

Treatment:

Drug: Metaraminol 2.7μg/kg/min