- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067817
Norepinephrine and Phenylephrine, Which Better for Elderly?
October 6, 2019 updated by: The Second Affiliated Hospital of Dalian Medical University
Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an Stroke Volume Variations(SVV) Fluid Guided Therapy in Elderly Undergoing Major Abdominal Surgery
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: xiao z yang, MD,PHD
- Phone Number: 0086 17709873399
- Email: xiaozhaoy2012@163.com
Study Locations
-
-
Liaoning
-
Dalian, Liaoning, China, 116000
- Recruiting
- The Second Hospital of Dalian Medical University
-
Contact:
- yang z Xiao, MD,PhD
- Phone Number: 0866-17709873399
- Email: 506222306@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
patient who was received the treatment of norepinephrine
Other Names:
|
Experimental: 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.
|
patient who was received the treatment of phenylephrine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemodynamics- (CO)cardiac output
Time Frame: 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
|
change from patient enters the operating room to end of operation, assessed up to the whole operation
|
Tissue perfusion and oxygenation-(DO2) Oxygen delivery;
Time Frame: 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) ;
|
change from beginning of operation to end of operation, assessed up to the whole operation
|
Tissue perfusion and oxygenation-(VO2)Oxygen consumption;
Time Frame: 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);
|
change from beginning of operation to end of operation, assessed up to the whole operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: xiao z yang, MD,PhD, The Second Affiliated Hospital of Dalian Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2019
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
January 30, 2020
Study Registration Dates
First Submitted
July 20, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 6, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Norepinephrine
- Phenylephrine
- Oxymetazoline
- Vasoconstrictor Agents
Other Study ID Numbers
- poster2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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