Norepinephrine and Phenylephrine, Which Better for Elderly?

The Second Affiliated Hospital of Dalian Medical University

Status and phase: Unknown; Phase 3

Conditions: Hypotension

Treatments: Drug: norepinephrine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04067817

poster2016

Details and patient eligibility

About

this is a prospective, double-blinded and single-center study. this study is based on the Stroke volume variation fluid guided therapy, to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 95 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• radical resection of colorectal or gastric cancers,
• age over 65 years old,
• surgical time longer than 2hours,
• the American Society of Anesthesiologists(ASA) classification of II or III

Exclusion criteria

• history of severe cardiovascular diseases,
• history of severe liver and kidney diseases,
• evidence of arrhythmia on EKG,
• use of positive end-expiratory pressure (PEEP) during mechanical ventilation;
• conditions with relative contraindication for arterial catheterization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

norepinephrine

Experimental group

Description:

Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, norepinephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered

Treatment:

Drug: norepinephrine

phenylephrine

Experimental group

Description:

Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, phenylephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered.

Treatment:

Drug: Phenylephrine