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Effect of Phenylephrine During Shoulder Arthroscopic Surgery

Primary Purpose

Disorder of Shoulder, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disorder of Shoulder focused on measuring shoulder, phenylephrine, hypotension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • shoulder arthroscopic surgery undergone beach chair position

Exclusion Criteria:

  • History of cerebrovascular event,
  • significant cardiac disease (New York Heart Association symptoms class ≥ 3)
  • uncontrolled hypertensive patients.
  • American society of anesthesiologist class 4,5

Sites / Locations

  • Haeundae paik hospital, inje university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Low dose phenylephrine

High dose phenylephrine

Normal saline

Arm Description

phenylephrine 0.5 mcg/kg/min

phenylephrine 1.0 mcg/kg/min .

normal saline for 5minutes

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 19, 2015
Last Updated
October 30, 2016
Sponsor
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT02585570
Brief Title
Effect of Phenylephrine During Shoulder Arthroscopic Surgery
Official Title
Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The beach chair position is associated with hypotension, risk of cerebral hypoperfusion, and cerebral injury. Sixty-six patients undergoing elective shoulder arthroscopic surgery are randomized to receive either phenylephrine low dose (0.5 mcg/kg/hr), phenylephrine high dose (1.0 mcg/kg/min), or normal saline 5 minute before being placed in the beach chair position. General anesthesia is induced with propofol, remifentanil and rocuronium (0.6 mg/kg) and the trachea intubated. Anesthesia is maintained with sevoflurane and remifentanil targeting for a BIS value 40-60. After hemodynamic stabilization, patients received on infusion of either phenylephrine high dose (1.0 mcg/kg/min), phenylephrine low dose (0.5 mcg/kg/hr) or normal saline 5 minute before being placed in the beach chair position. Following 15 minutes of infusion study drugs, measurements of mean arterial blood pressure and cardiac function (stroke volume variation, stroke volume index, and cardiac index) using Vigileo/Flotrac system were made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Shoulder, Anesthesia
Keywords
shoulder, phenylephrine, hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose phenylephrine
Arm Type
Experimental
Arm Description
phenylephrine 0.5 mcg/kg/min
Arm Title
High dose phenylephrine
Arm Type
Experimental
Arm Description
phenylephrine 1.0 mcg/kg/min .
Arm Title
Normal saline
Arm Type
No Intervention
Arm Description
normal saline for 5minutes
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Phenylephrine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
After being beach chair position during shoulder arthroscopic surgery. We measure the incidence of hypotension with invasive blood pressure (Arterial line catheterization).
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: shoulder arthroscopic surgery undergone beach chair position Exclusion Criteria: History of cerebrovascular event, significant cardiac disease (New York Heart Association symptoms class ≥ 3) uncontrolled hypertensive patients. American society of anesthesiologist class 4,5
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Hwa Lee, M.D
Organizational Affiliation
Haeundae paik hospital, inje university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haeundae paik hospital, inje university
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23518801
Citation
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.
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Effect of Phenylephrine During Shoulder Arthroscopic Surgery

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