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Completed

NCT Number: NCT05084599

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

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.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Umbilical artery blood pH

    Time frame: 30 seconds after delivery

    pH value of fetal umbilical artery blood

Secondary outcomes

  1. hypotension

    Time frame: Intraoperative

    Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery

  2. bradycardia

    Time frame: 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

  3. The incidence of nausea in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation.

  4. Umbilical artery blood base excess

    Time frame: 30sec after delivery

    base excess of fetal umbilical artery blood

  5. The incidence of vomiting in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2021
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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