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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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.
patient who was received the treatment of phenylephrine
Other Names:
  • vasopressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from patient enters the operating room to end of operation, assessed up to the whole operation
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) ;
change from beginning of operation to end of operation, assessed up to the whole operation
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);
change from beginning of operation to end of operation, assessed up to the whole operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: xiao z yang, MD,PhD, The Second Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2019

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

January 30, 2020

Study Registration Dates

First Submitted

July 20, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 6, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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