Cardiac Output Changes in Cesarean Section

NCT02759510 | Unknown Early Phase 1

• 1 other identifier: Renji-2016035k
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in cardiac output (CO) reduction.Norepinephrine acts not only as an α adrenoceptor receptor agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure the same asphenylephrine, meanwhile produce positive inotropic effect including increasing heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid the decline of CO. The purpose of this study is to evaluate the effect of norepinephrine and phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.

Conditions

Cardiac Output,Low; Hemodynamic Instability; Obstetrical Complication of Anesthesia

Keywords

cardiac output; norepinephrin; cesarean section

Outcome Measures

Primary Outcomes (1)

• cardiac output

  from baseline (before spinal injection) until 10 minutes after spinal injection

Secondary Outcomes (5)

• systolic blood pressure

  from baseline (before spinal injection) until 10 minutes after spinal injection

• heart rate

  from baseline (before spinal injection) until 10 minutes after spinal injection

• Apgar score

  1 min and 5 min after delivery

• Umbilical cord arterial blood pH/BE/Lac

  time at delivery

• umbilical plasma catecholamine concentration

  time at delivery

Study Arms (2)

phenylephrine

ACTIVE COMPARATOR

phenylejphrine (one bolus for 40 ug/ml)

Drug: Phenylephrine

norepinephrine

EXPERIMENTAL

norepinephrine (one bolus for 2 ug/ml)

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

Hypotension (systolic BP \<80% of baseline) will be treated with intravenous boluses of norepinephrine 2 μg.

norepinephrine

Phenylephrine DRUG

Hypotension (systolic BP \<80% of baseline) will be treated with intravenous boluses of phenylephrine 40 μg.

phenylephrine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age \>=18 years,\<=40 years;
• height 150-180 cm;
• weight 55-80 kg;
• full-term gestation (\>36 wk and \<41 wk)
• singleton pregnancy undergoing elective cesarean section under CSEA

You may not qualify if:

• contraindications to spinal anesthesia;
• patients with any complicated pregnancy;
• fetal compromise;
• need of emergency;
• in labor

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Zhenzhou He, MD

  Deparment of Anesthesia,South Campus,Renji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China

  STUDY CHAIR

Central Study Contacts

Qionghui Zhan, MD

CONTACT

8621-34506285; zhanqionghui328@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 3, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share