Arthroscopic Shoulder Surgery in the Beach-chair PositionNCT01687868
Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study
A study testing Dexmedetomidine in people with Arthroscopic Shoulder Surgery in the Beach-chair Position, run by Yonsei University at 1 site in South Korea.
Trial summary
Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for adverse neurologic events due to cerebral ischemia. Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response in… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arthroscopic Shoulder Surgery in the Beach-chair Position
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to May 2013
- 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
- ASA I-II
- Aged between 20 and 70 year
- general anesthesia for arthroscopic shoulder surgery in the beach-chair position
Who cannot join
- Congestive heart failure, coronary artery occlusive disease
- Bradycardia < 50 BPM, 2nd degree < AV block
- Poorly controlled hypertension
- ß blocker medication
- Coagulopathy
- Pregnancy, nursing
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine,Yonsei University Health System
Seoul, Seoul, 120-752
About this study
Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for adverse neurologic events due to cerebral ischemia.
Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the perioperative period.
Read more
dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically appropriate for reducing bleeding for arthroscopic operation field.
The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in patients undergoing arthroscopic shoulder surgery in the beach-chair position.
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine 0.7mcg/kg/hr continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine continuous infusion | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral oxygen saturation value
Before the anesthetic induction(T1), Before endotracheal intubation(T2), After endotracheal intubation(T3), Before the beach-chair position(T4), 5 minutes after the beach-chair position(T5), Before the operation(T6), 5 minutes after the incision(T7), After removal of the arthroscopy(T8), at the end of the operation(T9)
Measured: T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder Surgery in the Beach-chair PositionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687868
- Sponsor's protocol ID
- 4-2012-0351
- Status last verified
- Mar 2014
- First submitted
- 5 Sep 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study
- ClinicalTrials.gov ID
- NCT01687868
- Acronym / sponsor ID
- 4-2012-0351
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Sep 2012 (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.
Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for adverse neurologic events due to cerebral ischemia.
Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the perioperative period.
dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically appropriate for reducing bleeding for arthroscopic operation field.
The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in patients undergoing arthroscopic shoulder surgery in the beach-chair position.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine continuous infusion | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- Aged between 20 and 70 year
- general anesthesia for arthroscopic shoulder surgery in the beach-chair position
Key exclusion criteria (6 listed)
- Congestive heart failure, coronary artery occlusive disease
- Bradycardia < 50 BPM, 2nd degree < AV block
- Poorly controlled hypertension
- ß blocker medication
- Coagulopathy
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 |
|---|---|---|
| Dexmedetomidinedexmedetomidine 0.7mcg/kg/hr continuous infusion | Drug | dexmedetomidine continuous infusion |
Primary outcome
Regional cerebral oxygen saturation value
Time frame: T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery
Before the anesthetic induction(T1), Before endotracheal intubation(T2), After endotracheal intubation(T3), Before the beach-chair position(T4), 5 minutes after the beach-chair position(T5), Before the operation(T6), 5 minutes after the incision(T7), After removal of the arthroscopy(T8), at the end of the operation(T9)
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 5 Mar 2014.
Related trials for Arthroscopic Shoulder Surgery in the Beach-chair Position
Not yet recruiting
Nonoinvasive HPI in Beach-chair Position
the Intraoperative Hypotensionn, the Brain Exygenation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Arthroscopic Shoulder Surgery in the Beach-chair Position, run by Yonsei 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 3 inclusion and 6 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 5 Mar 2014. 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?
Regional cerebral oxygen saturation value (time frame: T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2014.