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NCT Number: NCT03833895

The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section

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Key information

Conditions

Cesarean Section Complications

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

About this study

  • Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring ( stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral vein (PV) blood gas during Cesarean Section.
  • Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under combined spinal-epidural anesthesia (CSEA),
  • American Society of Anesthesiologists (ASA) physical status I/II
  • 20 to 40 years old

Exclusion criteria

  • history of mental disorder or epilepsy,
  • tricyclic or imipramine antidepressant use,
  • central nervous system (CNS) disease,
  • preexisting or pregnancy-induced hypertension,
  • lumbar injury,
  • severe hypovolemia,
  • allergy
  • history of hypersensitivity to vasopressor
  • body mass index (BMI) >40 kg/m2,
  • infection at the puncture site

Treatment and study plan

norepinephrine

Drug

0.05ug/kg/min Norepinephrine during Cesarean Section Operation

Other names: Group 1 Elements

Phenylephrine

Drug

0.25ug/kg/min phenylephrine during Cesarean Section Operation

Other names: Group 2 Elements

Ringer's Solution

Drug

3 ml/kg/min of LR was administrated according to standard weight.

Other names: Group 3 Elements

Primary outcomes

  1. Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring

    Time frame: through study completion, an average of 24 hour

    Systolic blood pressure (SBP)

  2. Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring

    Time frame: Through study completion

    Diastolic blood pressure (DBP)

  3. Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring

    Time frame: An average of 24 hour

    Mean arterial pressure (MAP)

  4. Heart rate (HR) change as the one of hemodynamic outcome in general monitoring

    Time frame: Through the study completion, an average of 24 hour

    Heart rate (HR)

  5. Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient

    Time frame: Through study completion, an average of 24 hour

    Stroke volume (SV)

  6. Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient

    Time frame: Through study completion, an average of 24 hour

    Cardiac output (CO)

  7. Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient

    Time frame: Through study completion, an average of 24 hour

    Systemic vascular resistance (SVR)

Secondary outcomes

  1. The benefits to the fetus based on umbilical vein (UV) blood gas

    Time frame: Through study completion, an average of 24 hour

    The umbilical vein (UV) blood gas

  2. The benefits to the fetus based on umbilical artery (UA) blood gas

    Time frame: Through study completion, an average of 24 hour

    The umbilical artery (UA) blood gas

  3. The benefits to parturient based on peripheral vein (PV) blood gas

    Time frame: Through study completion, an average of 24 hour

    Peripheral vein (PV) blood gas

Interested in participating?

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Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Feb 10, 2020

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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