PainNCT02150759
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
A study testing Dexmedetomidine, Fentanyl and Ketamine in people with Pain, run by Inje University at 1 site in South Korea.
Trial summary
Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine lateral position for spinal anesthesia in femur proximal fracture patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Dexmedetomidine, Fentanyl and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- American society of anesthesiologists classification 1-3 patients
- >20 years old
Who cannot join
- patients refuse
- dementia patients, cooperation difficult patients
- anaphylaxis of dexmedetomidine, ketamine, local anesthetics
- heart problem (bradycardia, atrioventricular block)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
- Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
- lateral position for spinal anesthesia in femur proximal fracture patients
Read the detailed description
- Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.
- After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
- pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
- When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
- Patients will be injected propofol 10mg when they have agitation signs during operation.
- vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection
- Conditions
- Pain
- Being tested
- Dexmedetomidine, Fentanyl, Ketamine
- Keywords
- Dexmedetomidine, Ketamine, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
dexmedetomidine infusion during spinal anesthesia
FentanylDrug
Also called fentanyl citrate
add dexmedetomidine during position change
KetamineDrug
Also called ketamine HCl
add dexmedetomidine during position change
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine-ketamine | Experimental | Dexmedetomidine-ketamine group Receives: Drug: Dexmedetomidine; Drug: Ketamine |
| Dexmedetomidine-fentanyl | Active comparator | Dexmedetomidine-fentanyl group Receives: Drug: Dexmedetomidine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score Using Five Scales
We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.
Measured: average 10-20 minutes
Secondary outcomes (1)
Quality of Patient Positioning
We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.
Measured: average 10-20 minutes during spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 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
- Sang Eun Lee, MD, Study chair, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150759
- Sponsor's protocol ID
- 2014-027
- Status last verified
- Apr 2019
- First submitted
- 23 May 2014
- Last updated
- 29 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
- ClinicalTrials.gov ID
- NCT02150759
- Acronym / sponsor ID
- 2014-027
- Conditions
- Pain
- Keywords
- Dexmedetomidine, Ketamine, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
- lateral position for spinal anesthesia in femur proximal fracture patients
Detailed description
- Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.
- After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
- pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
- When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
- Patients will be injected propofol 10mg when they have agitation signs during operation.
- vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine-ketamine | Experimental | Drug: Dexmedetomidine, Drug: KetamineDexmedetomidine-ketamine group |
| Dexmedetomidine-fentanyl | Active comparator | Drug: Dexmedetomidine, Drug: FentanylDexmedetomidine-fentanyl group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists classification 1-3 patients
- >20 years old
Key exclusion criteria (4 listed)
- patients refuse
- dementia patients, cooperation difficult patients
- anaphylaxis of dexmedetomidine, ketamine, local anesthetics
- heart problem (bradycardia, atrioventricular block)
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 |
|---|---|---|
| DexmedetomidineAlso: Precedexdexmedetomidine infusion during spinal anesthesia | Drug | Dexmedetomidine-fentanyl, Dexmedetomidine-ketamine |
| FentanylAlso: fentanyl citrateadd dexmedetomidine during position change | Drug | Dexmedetomidine-fentanyl |
| KetamineAlso: ketamine HCladd dexmedetomidine during position change | Drug | Dexmedetomidine-ketamine |
Primary outcome
Pain Score Using Five Scales
Time frame: average 10-20 minutes
We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.
1 secondary outcome
Quality of Patient Positioning
Time frame: average 10-20 minutes during spinal anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sang Eun Lee, MD study chair
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 Dexmedetomidine, Fentanyl and Ketamine in people with Pain, 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 2 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 29 Apr 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. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score Using Five Scales (time frame: average 10-20 minutes). 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 29 Apr 2019.