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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03215797

Enrollment

Registered

2017-07-12

Start date

2016-09-30

Completion date

2016-12-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Therapy, Hypotension

Keywords

svv, norepinephrine, phenylephrine, elderly

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.

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.

Interventions

DRUGphenylephrine

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

DRUGNorepinephrine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to 95 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
the tissue oxygenation	from the beginning of surgery to the end of surgery	it means the tissue oxygen delivery and consumption

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026