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

NCT05084599 | Completed Phase 4

• 1 other identifier: 2021PHB455-001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Umbilical artery blood pH

  pH value of fetal umbilical artery blood

  30 seconds after delivery

Secondary Outcomes (5)

• hypotension

  Intraoperative

• bradycardia

  Intraoperative

• The incidence of nausea in pregnant women

  Intraoperative

• Umbilical artery blood base excess

  30sec after delivery

• The incidence of vomiting in pregnant women

  Intraoperative

Study Arms (2)

left-tilt group

PLACEBO COMPARATOR

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.

Drug: Metaraminol 2μg/kg/min

supine group

EXPERIMENTAL

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.

Drug: Metaraminol 2.7μg/kg/min

Interventions

Metaraminol 2.7μg/kg/min 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.

supine group

Metaraminol 2μg/kg/min 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.

left-tilt group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
• height 150-180 cm;
• American Society of Anesthesiologists (ASA) physical status II-III;
• body mass index (BMI) \<35 kg/m2.

You may not qualify if:

• transverse presentation, fetal macrosomia;
• uterine abnormalities (eg, large fibroids, bicornuate uterus);
• polyhydramnios;
• ruptured membranes, oligohydramnios;
• intrauterine growth restriction;
• gestational or nongestational hypertension, diabetes, or eclampsia;
• hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure;
• contraindications for combined spinal-epidural anesthesia;
• participants who declined to sign informed consent forms.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

Metaraminol

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Feng Yi

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: May 12, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)