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Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

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ClinicalTrials.gov Identifier: NCT03215797
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
The Second Affiliated Hospital of Dalian Medical University

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
Hypotension Fluid Therapy Drug: phenylephrine Drug: Norepinephrine 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


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

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




Primary Outcome Measures :
  1. the tissue oxygenation [ Time Frame: from the beginning of surgery to the end of surgery ]
    it means the tissue oxygen delivery and consumption



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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:

  • 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.
  Study Documents (Full-Text)

Documents provided by The Second Affiliated Hospital of Dalian Medical University:
Study Protocol  [PDF] January 21, 2018

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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: July 12, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
svv
norepinephrine
phenylephrine
elderly
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Norepinephrine
Adrenergic Agonists
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents