Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215797
• Other study ID #: Ph Vs N in SVV GDT
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2017
• Last updated: January 21, 2018
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria:

• Operation time should be equal or greater than 2h,

• Patients older than 65 years old,

• ASA ? or ?.

Exclusion Criteria:

• Clear arrhythmia,

• Need to apply PEEP,

• Peripheral vascular disease and arterial catheter contraindications.

Related Conditions & MeSH terms

• Fluid Therapy
• Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Outcome

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