Skip to main content
OpenTrials
Completed

NCT Number: NCT03215797

Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension Cardiovascular Diseases Fluid Therapy Vascular Diseases

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phenylephrine

Drug

phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.

Other names: α1-adrenergic receptor agonist, vasopressor

norepinephrine

Drug

Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension

Other names: noradrenaline, catecholamine

Primary outcomes

  1. the tissue oxygenation

    Time frame: from the beginning of surgery to the end of surgery

    it means the tissue oxygen delivery and consumption

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Dalian Medical University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.