Effect of Phenylephrine During Shoulder Arthroscopic Surgery
Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position
1 other identifier
interventional
66
1 country
1
Brief Summary
The purpose of this study is to determine whether phenylephrine infusion are effective in the prevention of hypotension after changing position to beach chair position during general anesthesia for shoulder arthroscopic surgery. Investigators hypothesized that by increasing arterial blood pressure with phenylephrine infusion, incidence of hypotension would be decreased.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
1 active site
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
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 1, 2016
October 1, 2016
11 months
October 19, 2015
October 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of hypotension
After being beach chair position during shoulder arthroscopic surgery. We measure the incidence of hypotension with invasive blood pressure (Arterial line catheterization).
30 minutes
Study Arms (3)
Low dose phenylephrine
EXPERIMENTALphenylephrine 0.5 mcg/kg/min
High dose phenylephrine
EXPERIMENTALphenylephrine 1.0 mcg/kg/min .
Normal saline
NO INTERVENTIONnormal saline for 5minutes
Interventions
Patients is received phenylephrine 1.0 mcg/kg/min or 0.5 mcg/kg/min for 5 minutes before being placed in the beach chair position.
Eligibility Criteria
You may qualify if:
- shoulder arthroscopic surgery undergone beach chair position
You may not qualify if:
- History of cerebrovascular event,
- significant cardiac disease (New York Heart Association symptoms class ≥ 3)
- uncontrolled hypertensive patients.
- American society of anesthesiologist class 4,5
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
Study Sites (1)
Haeundae paik hospital, inje university
Busan, 612-896, South Korea
Related Publications (1)
Soeding PF, Hoy S, Hoy G, Evans M, Royse CF. Effect of phenylephrine on the haemodynamic state and cerebral oxygen saturation during anaesthesia in the upright position. Br J Anaesth. 2013 Aug;111(2):229-34. doi: 10.1093/bja/aet024. Epub 2013 Mar 21.
PMID: 23518801BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ki Hwa Lee, M.D
Haeundae paik hospital, inje university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 23, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
November 1, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share