The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

NCT ID: NCT03833895

Last Updated: 2020-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2019-09-02

Brief Summary

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

Detailed Description

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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),

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1 Elements

Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

0.05ug/kg/min Norepinephrine during Cesarean Section Operation

Group 2 Elements

Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

0.25ug/kg/min phenylephrine during Cesarean Section Operation

Group 3 Elements

In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.

Group Type PLACEBO_COMPARATOR

Ringer's Solution

Intervention Type DRUG

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

Interventions

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Norepinephrine

0.05ug/kg/min Norepinephrine during Cesarean Section Operation

Intervention Type DRUG

Phenylephrine

0.25ug/kg/min phenylephrine during Cesarean Section Operation

Intervention Type DRUG

Ringer's Solution

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

Intervention Type DRUG

Other Intervention Names

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Group 1 Elements Group 2 Elements Group 3 Elements

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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China International Neuroscience Institution

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tianlong Wang, MD,PHD

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Feng K, Wang X, Feng X, Zhang J, Xiao W, Wang F, Zhou Q, Wang T. Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study. BMC Anesthesiol. 2020 Sep 7;20(1):229. doi: 10.1186/s12871-020-01145-0.

Reference Type DERIVED
PMID: 32894044 (View on PubMed)

Other Identifiers

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CINI-AD-201812-3

Identifier Type: -

Identifier Source: org_study_id

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