Norepinephrine and Phenylephrine, Which Better for Elderly?

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04067817
• Other study ID #: poster2016
• Status: Recruiting
• Phase: Phase 3
• Start date: October 6, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2019
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: xiao z yang, MD,PHD
• Phone: 17709873399
• Email: xiaozhaoy2012[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• norepinephrine
patient who was received the treatment of norepinephrine
• Phenylephrine
patient who was received the treatment of phenylephrine

Locations

Country	Name	City	State
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamics- (CO)cardiac output	(CO)cardiac output in Litres per minute. the indicator reflect the patients hemodynamic, which measured by the FloTrac/Vigileo 3.0	change from patient enters the operating room to end of operation, assessed up to the whole operation
Primary	Tissue perfusion and oxygenation-(DO2) Oxygen delivery;	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) ;	change from beginning of operation to end of operation, assessed up to the whole operation
Primary	Tissue perfusion and oxygenation-(VO2)Oxygen consumption;	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);	change from beginning of operation to end of operation, assessed up to the whole operation