The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

NCT03833895 | Completed Phase 2 DMC

• 1 other identifier: CINI-AD-201812-3
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section Complications

Keywords

Cesarean delivery

Outcome Measures

Primary Outcomes (7)

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

  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

  Diastolic blood pressure (DBP)

  Through study completion

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

  Mean arterial pressure (MAP)

  An average of 24 hour

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

  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

  Stroke volume (SV)

  Through study completion, an average of 24 hour

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

  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

  Systemic vascular resistance (SVR)

  Through study completion, an average of 24 hour

Secondary Outcomes (3)

• The benefits to the fetus based on 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

  Through study completion, an average of 24 hour

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

  Through study completion, an average of 24 hour

Study Arms (3)

Group 1 Elements

EXPERIMENTAL

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

Drug: Norepinephrine

Group 2 Elements

EXPERIMENTAL

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

Drug: Phenylephrine

Group 3 Elements

PLACEBO COMPARATOR

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

Drug: Ringer's Solution

Interventions

Norepinephrine DRUG

0.05ug/kg/min Norepinephrine during Cesarean Section Operation

Also known as: Group 1 Elements

Group 1 Elements

Phenylephrine DRUG

0.25ug/kg/min phenylephrine during Cesarean Section Operation

Also known as: Group 2 Elements

Group 2 Elements

Ringer's Solution DRUG

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

Also known as: Group 3 Elements

Group 3 Elements

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 40 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 32894044 DERIVED

MeSH Terms

Interventions

Norepinephrine; Metals, Alkali; Phenylephrine; Metals, Alkaline Earth; Ringer's Solution

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Elements; Inorganic Chemicals; Metals; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tianlong Wang, MD,PHD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: February 7, 2019
• Study Start: February 20, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 2, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)