Arthritis, DegenerativePhase 4NCT02784626
Intraoperative Sedatives and Postoperative Pain
A Phase 4 study testing Dexmedetomidine and Propofol in people with Arthritis, Degenerative, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arthritis, Degenerative
- What is being tested?
- Dexmedetomidine and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Sep 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee arthroplasty
- Age: 20 - 80 yrs
Who cannot join
- ASA classification ≥ 3
- Patient who do not want sedation during the surgery
- Patient who wants general anesthesia
- Cardiovascular disease
- Liver dysfunction
- Renal dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol
In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.
- Conditions
- Arthritis, Degenerative
- Being tested
- Dexmedetomidine, Propofol
- Keywords
- Dexmedetomidine, Propofol, Pain, Postoperative
- Medical subject headings
- Osteoarthritis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intraoperative sedation using dexmedetomidine
PropofolDrug
Intraoperative sedation using propofol
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Patients who received dexmedetomidine during the operation Receives: Drug: Dexmedetomidine |
| Propofol | Experimental | Patients who received propofol during the operation Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Postoperative pain score at postoperative 24 hours
Measured: Postoperative 24 hours
Secondary outcomes (3)
Rescue analgesics
Amount of rescue analgesics administered during 24 hours postoperatively
Measured: Postoperative 24 hours
Rescue analgesics
Amount of rescue analgesics administered during 48 hours postoperatively
Measured: Postoperative 48 hours
Visual analogue scale
Postoperative pain score at postoperative 48 hours
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, DegenerativeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784626
- Sponsor's protocol ID
- B-1603/339-005
- Status last verified
- Oct 2016
- First submitted
- 22 May 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol
- ClinicalTrials.gov ID
- NCT02784626
- Acronym / sponsor ID
- B-1603/339-005
- Conditions
- Arthritis, Degenerative
- Keywords
- Dexmedetomidine, Propofol, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 May 2016 (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.
In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatients who received dexmedetomidine during the operation |
| Propofol | Experimental | Drug: PropofolPatients who received propofol during the operation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing total knee arthroplasty
- Age: 20 - 80 yrs
Key exclusion criteria (6 listed)
- ASA classification ≥ 3
- Patient who do not want sedation during the surgery
- Patient who wants general anesthesia
- Cardiovascular disease
- Liver dysfunction
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 |
|---|---|---|
| DexmedetomidineIntraoperative sedation using dexmedetomidine | Drug | Dexmedetomidine |
| PropofolIntraoperative sedation using propofol | Drug | Propofol |
Primary outcome
Visual analogue scale
Time frame: Postoperative 24 hours
Postoperative pain score at postoperative 24 hours
3 secondary outcomes
Rescue analgesics
Time frame: Postoperative 24 hours
Rescue analgesics
Time frame: Postoperative 48 hours
Visual analogue scale
Time frame: Postoperative 48 hours
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 27 Oct 2016.
- 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.
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 Phase 4 study testing Dexmedetomidine and Propofol in people with Arthritis, Degenerative, run by Seoul National University Bundang Hospital 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 2 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 27 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual analogue scale (time frame: Postoperative 24 hours). 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 27 Oct 2016.