Rotator Cuff TearNCT02643017
Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
A study testing Dexmedetomidine and normal saline in people with Rotator Cuff Tear, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Dexmedetomidine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2015to 16 Aug 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients undergoing shoulder arthroscopic surgery with beach chair position
Who cannot join
- Patients with respiratory disease
- Patients with cardiac disease
- Patients with cerebrovascular disease
- patients with uncontrolled hypertension
- Patients with dementia
- Patients with psychiatric disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.
- Conditions
- Rotator Cuff Tear
- Being tested
- Dexmedetomidine, normal saline
- Keywords
- cognitive function, desflurane, dexmedetomidine
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
normal salineDrug
Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
| Dex | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative cognitive decline assessed by mini-mental state examination
to compare cognitive decline after surgery between control and dexmedetomidine group with mini-mental state examination.
Measured: from 1 day before surgery to postoperative 1 day
Number of patients with postoperative cognitive decline assessed by a battery of psychometric test
to compare cognitive decline after surgery between control and dexmedetomidine group with a battery of psychometric test. The battery consists of copy geometric form test, two-dimensional model test, grooved pegboard test, colored block design test, puzzle test, clock drawing test.
Measured: from 1 day before surgery to postoperative 1 day
Secondary outcomes (1)
Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients
S100ß protein is the biologic marker for neuroinflammation
Measured: from 5 min after induction of anesthesia to an 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start11 Dec 2015
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 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
- NCT02643017
- Sponsor's protocol ID
- 4-2015-0621
- Status last verified
- Jan 2019
- First submitted
- 15 Dec 2015
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
- ClinicalTrials.gov ID
- NCT02643017
- Acronym / sponsor ID
- 4-2015-0621
- Conditions
- Rotator Cuff Tear
- Keywords
- cognitive function, desflurane, dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Dec 2015 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 30 Dec 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.
Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Drug: normal saline |
| Dex | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients undergoing shoulder arthroscopic surgery with beach chair position
Key exclusion criteria (6 listed)
- Patients with respiratory disease
- Patients with cardiac disease
- Patients with cerebrovascular disease
- patients with uncontrolled hypertension
- Patients with dementia
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 |
|---|---|---|
| DexmedetomidineAdministration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery. | Drug | Dex |
| normal salineAdministration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery. | Drug | normal saline |
Primary outcome
Number of patients with postoperative cognitive decline assessed by mini-mental state examination
Time frame: from 1 day before surgery to postoperative 1 day
to compare cognitive decline after surgery between control and dexmedetomidine group with mini-mental state examination.
Number of patients with postoperative cognitive decline assessed by a battery of psychometric test
Time frame: from 1 day before surgery to postoperative 1 day
to compare cognitive decline after surgery between control and dexmedetomidine group with a battery of psychometric test. The battery consists of copy geometric form test, two-dimensional model test, grooved pegboard test, colored block design test, puzzle test, clock drawing test.
1 secondary outcome
Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients
Time frame: from 5 min after induction of anesthesia to an 1 hour after surgery
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 25 Jan 2019.
- Individual participant dataSharing planned: No. There is no plan to share the data.
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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.
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 and normal saline in people with Rotator Cuff Tear, 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 1 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 25 Jan 2019. 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. Some participants in this study may receive a placebo. 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?
Number of patients with postoperative cognitive decline assessed by mini-mental state examination (time frame: from 1 day before surgery to postoperative 1 day). The study lists 2 primary outcomes in all. 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 25 Jan 2019.