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Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Primary Purpose

Hypotension, Fluid Therapy

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

phenylephrine

Norepinephrine

About this trial

This is an interventional treatment trial for Hypotension focused on measuring svv, norepinephrine, phenylephrine, elderly

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

phenylephrine and norepinephrine

Norepinephrine and phenylephrine

Arm Description

Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.

Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension

Outcomes

Primary Outcome Measures

the tissue oxygenation

it means the tissue oxygen delivery and consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT03215797

First Posted

April 9, 2017

Last Updated

January 21, 2018

Sponsor

The Second Affiliated Hospital of Dalian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03215797

Brief Title

Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Affiliated Hospital of Dalian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension, Fluid Therapy

Keywords

svv, norepinephrine, phenylephrine, elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

phenylephrine and norepinephrine

Arm Type

Active Comparator

Arm Description

Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.

Arm Title

Norepinephrine and phenylephrine

Arm Type

Other

Arm Description

Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension

Intervention Type

Drug

Intervention Name(s)

phenylephrine

Other Intervention Name(s)

α1-adrenergic receptor agonist, vasopressor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Norepinephrine

Other Intervention Name(s)

noradrenaline, catecholamine

Intervention Description

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

Primary Outcome Measure Information:

Title

the tissue oxygenation

Description

it means the tissue oxygen delivery and consumption

Time Frame

from the beginning of surgery to the end of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

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Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

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