Norepinephrine and Phenylephrine, Which Better for Elderly?

Phase 3

• Conditions: Hypotension
• Interventions: Drug: norepinephrine; Drug: Phenylephrine

• Registration Number: NCT04067817
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-20
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-28
• Study Start: 2019-10-06
• Last Update Submitted: 2019-10-06
• Last Update Posted: 2019-10-08
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrine	norepinephrine	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
phenylephrine	Phenylephrine	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.

Primary Outcome Measures

Name	Time	Method
hemodynamics- (CO)cardiac output	change from patient enters the operating room to end of operation, assessed up to the whole operation	(CO)cardiac output in Litres per minute. the indicator reflect the patients hemodynamic, which measured by the FloTrac/Vigileo 3.0
Tissue perfusion and oxygenation-(DO2) Oxygen delivery;	change from beginning of operation to end of operation, assessed up to the whole operation	Blood samples from the radial artery and internal jugular vein were taken at the same time in three time points respectively to measure arterial and venous blood gas, and Measured tissue oxygenation according to Fick equation:DO2(ml/min/m2)=CaO2×10×CI, Arterial oxygen content (CaO2)=Arterial hemoglobin concentration(Hba)×1.36×arterial oxygen saturation(SaO2) + 0.0031×arterial oxygen pressure (PaO2) ;
Tissue perfusion and oxygenation-(VO2)Oxygen consumption;	change from beginning of operation to end of operation, assessed up to the whole operation	Blood samples from the radial artery and internal jugular vein were taken at the same time in three time points respectively to measure arterial and venous blood gas, and Measured tissue oxygenation according to Fick equation:VO2(ml/min/m2)= (CaO2-CcvO2)×CI×10, Intravenous oxygen content (CcvO2)= Intravenous hemoglobin concentration (Hbv)×1.36×Venous oxygen saturation (ScvO2) + 0.0031×venous oxygen pressure (PcvO2);

Trial Locations

Locations (1)

The Second Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China