Phenylephrine or Norepinephrine for a Better Hemodynamic Stability

NCT ID: NCT03215797

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Hypotension; Fluid Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

phenylephrine and norepinephrine

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

Group Type: ACTIVE_COMPARATOR

phenylephrine

Intervention Type: DRUG

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

Norepinephrine

Intervention Type: DRUG

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

Norepinephrine and phenylephrine

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

Group Type: OTHER

phenylephrine

Intervention Type: DRUG

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

Norepinephrine

Intervention Type: DRUG

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

Interventions

phenylephrine

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

Intervention Type: DRUG

Norepinephrine

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

Intervention Type: DRUG

Other Intervention Names

α1-adrenergic receptor agonist; vasopressor; noradrenaline; catecholamine

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Ph Vs N in SVV GDT

Identifier Type: -

Identifier Source: org_study_id