Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

Phase 3

Completed

• Conditions: Hypotension; Fluid Therapy
• Interventions: Drug: phenylephrine; Drug: Norepinephrine

• Registration Number: NCT03215797
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Study First Submitted: 2017-04-09
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Last Update Submitted: 2018-01-21
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norepinephrine and phenylephrine	phenylephrine	Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension
phenylephrine and norepinephrine	phenylephrine	Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.
phenylephrine and norepinephrine	Norepinephrine	Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.
Norepinephrine and phenylephrine	Norepinephrine	Phenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension

Primary Outcome Measures

Name	Time	Method
the tissue oxygenation	from the beginning of surgery to the end of surgery	it means the tissue oxygen delivery and consumption