Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

January 21, 2018 updated by: The Second Affiliated Hospital of Dalian Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: phenylephrine and norepinephrine
Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.
Drug: phenylephrine
phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
Other Names:
  • vasopressor
  • α1-adrenergic receptor agonist
Drug: Norepinephrine
Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
Other Names:
  • noradrenaline
  • catecholamine
Other: Norepinephrine and phenylephrine
Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension
Drug: phenylephrine
phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
Other Names:
  • vasopressor
  • α1-adrenergic receptor agonist
Drug: Norepinephrine
Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
Other Names:
  • noradrenaline
  • catecholamine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 21, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ph Vs N in SVV GDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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