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Completed

NCT Number: NCT03507387

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

About this study

Hypotension often occurred in parturients undergoing cesarean section in spinal anesthesia. This study aims to determine whether preventive intramuscular phenylephrine can better the fetal acid-base state and maternal hemodynamics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years to 40 years.
  • Elective cesarean section
  • American Society of Anesthesiologists (ASA) grade from I to Ⅱ, height from 150 cm to 180 cm, BMI<40kg/m2
  • Singleton pregnancy
  • Without pregnancy complications

Exclusion criteria

  • Multiple pregnancy
  • Preoperative bradycardia
  • Coagulation dysfunction
  • Parturients with hypertension, diabetes, eclampsia and other pregnancy complications.

Treatment and study plan

Phenylephrine

Drug

5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .

Other names: Metasympatol

normal saline

Drug

1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.

Other names: Physiological saline

Bupivacaine

Drug

All patients will receive spinal anesthesia with bupivacaine.

Other names: Marcaine

Primary outcomes

  1. Umbilical artery potential of hydrogen (pH)

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

Secondary outcomes

  1. Umbilical venous potential of hydrogen (pH)

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  2. Umbilical artery base excess

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  3. Umbilical venous base excess

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  4. Umbilical artery partial pressure of oxygen (PaO2)

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  5. Umbilical venous partial pressure of oxygen (PaO2)

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  6. Umbilical artery partial pressure of carbon dioxide (PaCO2)

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  7. Umbilical venous partial pressure of carbon dioxide (PaCO2)

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  8. Umbilical artery lactate

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  9. Umbilical venous lactate

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  10. Umbilical artery glucose

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  11. Umbilical venous glucose

    Time frame: after the baby is delivered

    detected by a blood gase analyzer

  12. Incidence of fetal acidosis

    Time frame: after the baby is delivered

    Umbilical artery pH value<7.20

  13. Incidence of hypotension

    Time frame: intraoperative

    decrease of systolic blood pressure>20% baseline values

  14. Incidence of hypertension

    Time frame: intraoperative

    increase of systolic blood pressure>20% baseline values

  15. Incidence of bradycardia

    Time frame: intraoperative

    heart rate <50 bpm

  16. Incidence of nausea or vomit

    Time frame: intraoperative

    observed by the anesthesiologist

Sponsors and collaborators

Lead sponsor

Xuzhou Medical University

Other

Registry information

Official study title

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Jul 5, 2019

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.

Published trials that share one or more normalized conditions with this study.