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Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Primary Purpose

Hypotension, Fluid Therapy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
phenylephrine
Norepinephrine
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 svv, norepinephrine, phenylephrine, elderly

Eligibility Criteria

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

Inclusion Criteria:

  • Operation time should be equal or greater than 2h,
  • Patients older than 65 years old,
  • ASA Ⅱ or Ⅲ.

Exclusion Criteria:

  • Clear arrhythmia,
  • Need to apply PEEP,
  • Peripheral vascular disease and arterial catheter contraindications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    phenylephrine and norepinephrine

    Norepinephrine and phenylephrine

    Arm Description

    Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.

    Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension

    Outcomes

    Primary Outcome Measures

    the tissue oxygenation
    it means the tissue oxygen delivery and consumption

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2017
    Last Updated
    January 21, 2018
    Sponsor
    The Second Affiliated Hospital of Dalian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03215797
    Brief Title
    Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
    Official Title
    Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an SVV Fluid Guided Therapy in Elderly Undergoing Radical Resection of Colon Cancer Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. The aim of this study is to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.
    Detailed Description
    Fluid management has a great influence on patient's morbidity, mortality and on the overall outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging, elderly presenting for surgery are also increasing. This population is known for the multiple comorbidities and physiological changes which makes them prone to dehydration and hypotension. That's when we are going to use either Norepinephrine in one group or Phenylephrine in the other and compare the effects of both vasopressors. Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    phenylephrine and norepinephrine
    Arm Type
    Active Comparator
    Arm Description
    Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.
    Arm Title
    Norepinephrine and phenylephrine
    Arm Type
    Other
    Arm Description
    Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension
    Intervention Type
    Drug
    Intervention Name(s)
    phenylephrine
    Other Intervention Name(s)
    α1-adrenergic receptor agonist, vasopressor
    Intervention Description
    phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine
    Other Intervention Name(s)
    noradrenaline, catecholamine
    Intervention Description
    Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
    Primary Outcome Measure Information:
    Title
    the tissue oxygenation
    Description
    it means the tissue oxygen delivery and consumption
    Time Frame
    from the beginning of surgery to the end of surgery

    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: Operation time should be equal or greater than 2h, Patients older than 65 years old, ASA Ⅱ or Ⅲ. Exclusion Criteria: Clear arrhythmia, Need to apply PEEP, Peripheral vascular disease and arterial catheter contraindications.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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