Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypotension, Fluid Therapy

Intervention / Treatment
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* Drug: phenylephrine
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: phenylephrine and norepinephrine<br>Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension. | Drug: phenylephrine<br>* phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.<br>* Other names: vasopressor;Drug: Norepinephrine<br>* Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension<br>* Other names: catecholamine;|
| Other: Norepinephrine and phenylephrine<br>Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension | Drug: phenylephrine<br>* phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.<br>* Other names: vasopressor;Drug: Norepinephrine<br>* Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension<br>* Other names: catecholamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the tissue oxygenation | it means the tissue oxygen delivery and consumption | from the beginning of surgery to the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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svv, norepinephrine, phenylephrine, elderly