Norepinephrine and Phenylephrine, Which Better for Elderly?

Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an Stroke Volume Variations(SVV) Fluid Guided Therapy in Elderly Undergoing Major Abdominal Surgery

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04067817

Enrollment

100

Registered

2019-08-28

Start date

2019-10-06

Completion date

2020-01-30

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Goal-directed Fluid Therapy, norepinephrine, phenylephrine, elderly

Brief summary

this is a prospective, double-blinded and single-center study. this study is based on the Stroke volume variation fluid guided therapy, to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.

Interventions

DRUGnorepinephrine

patient who was received the treatment of norepinephrine

DRUGPhenylephrine

patient who was received the treatment of phenylephrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to 95 Years

Healthy volunteers

Yes

Inclusion criteria

* radical resection of colorectal or gastric cancers, * age over 65 years old, * surgical time longer than 2hours, * the American Society of Anesthesiologists(ASA) classification of II or III

Exclusion criteria

* history of severe cardiovascular diseases, * history of severe liver and kidney diseases, * evidence of arrhythmia on EKG, * use of positive end-expiratory pressure (PEEP) during mechanical ventilation; * conditions with relative contraindication for arterial catheterization

Design outcomes

Primary

Measure	Time frame	Description
hemodynamics- (CO)cardiac output	change from patient enters the operating room to end of operation, assessed up to the whole operation	(CO)cardiac output in Litres per minute. the indicator reflect the patients hemodynamic, which measured by the FloTrac/Vigileo 3.0
Tissue perfusion and oxygenation-(DO2) Oxygen delivery;	change from beginning of operation to end of operation, assessed up to the whole operation	Blood samples from the radial artery and internal jugular vein were taken at the same time in three time points respectively to measure arterial and venous blood gas, and Measured tissue oxygenation according to Fick equation:DO2(ml/min/m2)=CaO2×10×CI, Arterial oxygen content (CaO2)=Arterial hemoglobin concentration(Hba)×1.36×arterial oxygen saturation(SaO2) + 0.0031×arterial oxygen pressure (PaO2) ;
Tissue perfusion and oxygenation-(VO2)Oxygen consumption;	change from beginning of operation to end of operation, assessed up to the whole operation	Blood samples from the radial artery and internal jugular vein were taken at the same time in three time points respectively to measure arterial and venous blood gas, and Measured tissue oxygenation according to Fick equation:VO2(ml/min/m2)= (CaO2-CcvO2)×CI×10, Intravenous oxygen content (CcvO2)= Intravenous hemoglobin concentration (Hbv)×1.36×Venous oxygen saturation (ScvO2) + 0.0031×venous oxygen pressure (PcvO2);

Countries

China

Contacts

Primary Contactxiao z yang, MD,PHD

xiaozhaoy2012@163.com17709873399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026