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Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Sponsor
The Second Affiliated Hospital of Dalian Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03215797
Collaborator
(none)
40
Enrollment
2
Arms
3
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 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 SVV Fluid Guided Therapy in Elderly Undergoing Radical Resection of Colon Cancer Surgery
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: phenylephrine and norepinephrine

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

Drug: phenylephrine
phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
Other Names:
  • α1-adrenergic receptor agonist
  • vasopressor

    • Drug: Norepinephrine
    Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
    Other Names:
  • noradrenaline
  • catecholamine

    		•
    Other: Norepinephrine and phenylephrine

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

    Drug: phenylephrine
    phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
    Other Names:
  • α1-adrenergic receptor agonist
  • vasopressor

    • Drug: Norepinephrine
    Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
    Other Names:
  • noradrenaline
  • catecholamine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the tissue oxygenation [from the beginning of surgery to the end of surgery]

      it means the tissue oxygen delivery and consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Second Affiliated Hospital of Dalian Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    The Second Affiliated Hospital of Dalian Medical University
    ClinicalTrials.gov Identifier:
    NCT03215797
    Other Study ID Numbers:
    • Ph Vs N in SVV GDT
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    svv
    norepinephrine
    phenylephrine
    elderly
    Additional relevant MeSH terms:
    Hypotension
    Phenylephrine
    Oxymetazoline
    Norepinephrine
    Adrenergic Agonists

    Study Results

    No Results Posted as of Jan 23, 2018