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Norepinephrine and Phenylephrine, Which Better for Elderly?

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ClinicalTrials.gov Identifier: NCT04067817
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
The Second Affiliated Hospital of Dalian Medical University

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.

Condition or disease Intervention/treatment Phase
Hypotension Drug: norepinephrine Drug: Phenylephrine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 6, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020


Arm Intervention/treatment
Experimental: norepinephrine
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
Drug: norepinephrine
patient who was received the treatment of norepinephrine
Other Names:
  • noradrenaline
  • vasopressor

Experimental: phenylephrine
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.
Drug: Phenylephrine
patient who was received the treatment of phenylephrine
Other Name: vasopressor




Primary Outcome Measures :
  1. hemodynamics- (CO)cardiac output [ Time Frame: 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

  2. Tissue perfusion and oxygenation-(DO2) Oxygen delivery; [ Time Frame: 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) ;

  3. Tissue perfusion and oxygenation-(VO2)Oxygen consumption; [ Time Frame: 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);



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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067817


Contacts
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Contact: xiao z yang, MD,PHD 17709873399 ext 0086 xiaozhaoy2012@163.com

Locations
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China, Liaoning
The Second Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116000
Contact: yang z Xiao, MD,PhD    0866-17709873399    506222306@qq.com   
Sponsors and Collaborators
The Second Affiliated Hospital of Dalian Medical University
Investigators
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Study Director: xiao z yang, MD,PhD The Second Affiliated Hospital of Dalian Medical University
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Responsible Party: The Second Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT04067817    
Other Study ID Numbers: poster2016
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Affiliated Hospital of Dalian Medical University:
Goal-directed Fluid Therapy
norepinephrine
phenylephrine
elderly
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Norepinephrine
Vasoconstrictor Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents