Norepinephrine and Phenylephrine, Which Better for Elderly?

NCT04067817 | Unknown Phase 3

• 1 other identifier: poster2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

Goal-directed Fluid Therapy; norepinephrine; phenylephrine; elderly

Outcome Measures

Primary Outcomes (3)

• hemodynamics- (CO)cardiac output

  (CO)cardiac output in Litres per minute. the indicator reflect the patients hemodynamic, which measured by the FloTrac/Vigileo 3.0

  change from patient enters the operating room to end of operation, assessed up to the whole operation

• Tissue perfusion and oxygenation-(DO2) Oxygen delivery;

  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) ;

  change from beginning of operation to end of operation, assessed up to the whole operation

• Tissue perfusion and oxygenation-(VO2)Oxygen consumption;

  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);

  change from beginning of operation to end of operation, assessed up to the whole operation

Study Arms (2)

norepinephrine

EXPERIMENTAL

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

Drug: norepinephrine

phenylephrine

EXPERIMENTAL

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.

Drug: Phenylephrine

Interventions

norepinephrine DRUG

patient who was received the treatment of norepinephrine

Also known as: noradrenaline, vasopressor

norepinephrine

Phenylephrine DRUG

patient who was received the treatment of phenylephrine

Also known as: vasopressor

phenylephrine

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine; Vasoconstrictor Agents; Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• xiao z yang, MD,PhD

  The Second Affiliated Hospital of Dalian Medical University

  STUDY DIRECTOR

Central Study Contacts

xiao z yang, MD,PHD

CONTACT

17709873399; xiaozhaoy2012@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: August 28, 2019
• Study Start: October 6, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-07

Locations

CN (1)