Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an SVV Fluid Guided Therapy in Elderly Undergoing Radical Resection of Colon Cancer Surgery
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2016
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 9, 2017
CompletedFirst Posted
Study publicly available on registry
July 12, 2017
CompletedJanuary 23, 2018
April 1, 2017
3 months
April 9, 2017
January 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the tissue oxygenation
it means the tissue oxygen delivery and consumption
from the beginning of surgery to the end of surgery
Study Arms (2)
phenylephrine and norepinephrine
ACTIVE COMPARATORPhenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of perioperative hypotension.
Norepinephrine and phenylephrine
OTHERPhenylephrine 100ug/ml and Norepinephrine 5ug/ml IV infusion in postoperative time in case of hypotension
Interventions
phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
Eligibility Criteria
You may qualify if:
- Operation time should be equal or greater than 2h,
- Patients older than 65 years old,
- ASA Ⅱ or Ⅲ.
You may not qualify if:
- Clear arrhythmia,
- Need to apply PEEP,
- Peripheral vascular disease and arterial catheter contraindications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
April 9, 2017
First Posted
July 12, 2017
Study Start
September 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 23, 2018
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share