NCT03215797

Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Second Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypotension
• Fluid Therapy

Interventions

Type	Name	Description
DRUG	phenylephrine	phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
DRUG	Norepinephrine	Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2017-07-12
• Last updated: 2018-01-23