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

NCT ID: NCT05084599

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2024-01-31

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

left-tilt group

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.

Group Type: PLACEBO_COMPARATOR

Metaraminol 2μg/kg/min

Intervention Type: DRUG

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.

supine group

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.

Group Type: EXPERIMENTAL

Metaraminol 2.7μg/kg/min

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Feng, MD

Head of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Yi

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2021PHB455-001

Identifier Type: -

Identifier Source: org_study_id