Disorder of ShoulderNCT02585570
Effect of Phenylephrine During Shoulder Arthroscopic Surgery
A study testing Phenylephrine in people with Disorder of Shoulder and Anesthesia, run by Inje University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Disorder of Shoulder, Anesthesia
- What is being tested?
- Phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- shoulder arthroscopic surgery undergone beach chair position
Who cannot join
- History of cerebrovascular event,
- significant cardiac disease (New York Heart Association symptoms class ≥ 3)
- uncontrolled hypertensive patients.
- American society of anesthesiologist class 4,5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position
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.
Read the 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.
- Conditions
- Disorder of Shoulder, Anesthesia
- Being tested
- Phenylephrine
- Keywords
- shoulder, phenylephrine, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Phenylephrine hydrochloride
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.
| Study group | Role | What they receive |
|---|---|---|
| Low dose phenylephrine | Experimental | phenylephrine 0.5 mcg/kg/min Receives: Drug: Phenylephrine |
| High dose phenylephrine | Experimental | phenylephrine 1.0 mcg/kg/min . Receives: Drug: Phenylephrine |
| Normal saline | No intervention | normal saline for 5minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hwa Lee, Inje University
- Investigators
- Ki Hwa Lee, M.D, Principal investigator, Haeundae paik hospital, inje university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585570
- Sponsor's protocol ID
- 2015-096
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23518801
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT02585570
- Acronym / sponsor ID
- 2015-096
- Conditions
- Disorder of Shoulder, Anesthesia
- Keywords
- shoulder, phenylephrine, hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose phenylephrine | Experimental | Drug: Phenylephrinephenylephrine 0.5 mcg/kg/min |
| High dose phenylephrine | Experimental | Drug: Phenylephrinephenylephrine 1.0 mcg/kg/min . |
| Normal saline | No intervention | –normal saline for 5minutes |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- shoulder arthroscopic surgery undergone beach chair position
Key exclusion criteria (4 listed)
- History of cerebrovascular event,
- significant cardiac disease (New York Heart Association symptoms class ≥ 3)
- uncontrolled hypertensive patients.
- American society of anesthesiologist class 4,5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenylephrineAlso: Phenylephrine hydrochloridePatients 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. | Drug | High dose phenylephrine, Low dose phenylephrine |
Primary outcome
Incidence of hypotension
Time frame: 30 minutes
After being beach chair position during shoulder arthroscopic surgery. We measure the incidence of hypotension with invasive blood pressure (Arterial line catheterization).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Background: PubMed 23518801Soeding 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Hwa Lee, M.D principal investigator
Haeundae paik hospital, inje university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine in people with Disorder of Shoulder and Anesthesia, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.