The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

February 6, 2020 updated by: China International Neuroscience Institution

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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),

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 Elements
Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation
Drug: Norepinephrine
0.05ug/kg/min Norepinephrine during Cesarean Section Operation
Other Names:
  • Group 1 Elements
EXPERIMENTAL: Group 2 Elements
Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation
Drug: Phenylephrine
0.25ug/kg/min phenylephrine during Cesarean Section Operation
Other Names:
  • Group 2 Elements
PLACEBO_COMPARATOR: Group 3 Elements
In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.
Drug: Ringer's Solution
3 ml/kg/min of LR was administrated according to standard weight.
Other Names:
  • Group 3 Elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 24 hour
Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
Time Frame: Through study completion
Diastolic blood pressure (DBP)
Through study completion
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)
An average of 24 hour
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)
Through the study completion, an average of 24 hour
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)
Through study completion, an average of 24 hour
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)
Through study completion, an average of 24 hour
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)
Through study completion, an average of 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 24 hour
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
Through study completion, an average of 24 hour
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
Through study completion, an average of 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China International Neuroscience Institution

Investigators

  • Study Chair: Tianlong Wang, MD,PHD, Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 20, 2019

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 2, 2019

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (ACTUAL)

February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINI-AD-201812-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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