Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

The Second Affiliated Hospital of Dalian Medical University

Status and phase: Completed; Phase 3

Conditions: Hypotension; Fluid Therapy

Treatments: Drug: phenylephrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03215797

Ph Vs N in SVV GDT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 60 to 95 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

phenylephrine and norepinephrine

Active Comparator group

Description:

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

Treatment:

Drug: Norepinephrine

Drug: phenylephrine

Norepinephrine and phenylephrine

Other group

Description:

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

Treatment:

Drug: Norepinephrine

Drug: phenylephrine