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Norepinephrine and Phenylephrine, Which Better for Elderly?

Primary Purpose

Hypotension

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
norepinephrine
Phenylephrine
Sponsored by
The Second Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Goal-directed Fluid Therapy, norepinephrine, phenylephrine, elderly

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Second Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

norepinephrine

phenylephrine

Arm Description

Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, norepinephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered

Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, phenylephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered.

Outcomes

Primary Outcome Measures

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
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) ;
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);

Secondary Outcome Measures

Full Information

First Posted
July 20, 2019
Last Updated
October 6, 2019
Sponsor
The Second Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04067817
Brief Title
Norepinephrine and Phenylephrine, Which Better for Elderly?
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Dalian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Goal-directed Fluid Therapy, norepinephrine, phenylephrine, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
norepinephrine
Arm Type
Experimental
Arm Description
Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, norepinephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered
Arm Title
phenylephrine
Arm Type
Experimental
Arm Description
Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, phenylephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered.
Intervention Type
Drug
Intervention Name(s)
norepinephrine
Other Intervention Name(s)
noradrenaline, vasopressor
Intervention Description
patient who was received the treatment of norepinephrine
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
vasopressor
Intervention Description
patient who was received the treatment of phenylephrine
Primary Outcome Measure Information:
Title
hemodynamics- (CO)cardiac output
Description
(CO)cardiac output in Litres per minute. the indicator reflect the patients hemodynamic, which measured by the FloTrac/Vigileo 3.0
Time Frame
change from patient enters the operating room to end of operation, assessed up to the whole operation
Title
Tissue perfusion and oxygenation-(DO2) Oxygen delivery;
Description
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) ;
Time Frame
change from beginning of operation to end of operation, assessed up to the whole operation
Title
Tissue perfusion and oxygenation-(VO2)Oxygen consumption;
Description
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);
Time Frame
change from beginning of operation to end of operation, assessed up to the whole operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiao z yang, MD,PHD
Phone
17709873399
Ext
0086
Email
xiaozhaoy2012@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiao z yang, MD,PhD
Organizational Affiliation
The Second Affiliated Hospital of Dalian Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yang z Xiao, MD,PhD
Phone
0866-17709873399
Email
506222306@qq.com

12. IPD Sharing Statement

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Norepinephrine and Phenylephrine, Which Better for Elderly?

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