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Completed

NCT Number: NCT04991662

Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.

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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

Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

About this study

At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .

Who can participate

Healthy volunteers accepted: Yes

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

Drug

Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Other names: M group

Phenylephrine

Drug

Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Other names: P group

norepinephrine

Drug

Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.

Other names: N group

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

  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

Xuzhou Medical University

Other

Registry information

Official study title

Effect of Three Weight-adjusted Vasopressors for With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2021
Registry last updated
Dec 30, 2021

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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