Lower Limb FracturePhase 4NCT04675372
Dexmedetomidine Facilitate Analgesia
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Lower Limb Fracture and Nerve Block, run by China International Neuroscience Institution at 1 site in China.
Trial summary
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Limb Fracture, Nerve Block
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2021to 3 Aug 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged from 18 to 80 years old
- American Association of anesthesiologists (ASA) grade Ⅱ ~ IV
- body mass index (BMI) 18.5-40
- planning undergoing peripheral nerve block
Who cannot join
- incomplete effect of nerve block
- Alzheimer's disease
- implanted cardiac pacemakers
- mental illness
- epilepsy
- autonomic nervous system diseases
- projected the duration of the operation was more than 3 hours
Trial locations and contacts
1 site in 1 country.
China1 site
China International Neuroscience
Beijing, Beijing Municipality, 100053
About this study
Official title: Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.
Read the detailed description
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.
- Conditions
- Lower Limb Fracture, Nerve Block
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- Dexmedetomidine, nociceptive index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion
MidazolamDrug
Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX) Receives: Drug: Dexmedetomidine |
| Group 2 | Active comparator | Midazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
nociceptive index
qNOX reached target 80 during drug infusion（qNOX<80 Adequate；qNOX>80 unadequate）
Measured: During operation
Secondary outcomes (5)
hypoxemia
incidence of hypoxemia(SPO2<95%Mild hypoxemia,SPO2<90% moderate hypoxemia, SPO2<85% severe hypoxemia)
Measured: During operation
systolic blood pressure
Change of systolic blood pressure(SBP)
Measured: During operation
heart rate
fluctuation of heart rate(HR)
Measured: During operation
diastolic blood pressure
fluctuation of diastolic blood pressure(DBP)
Measured: During operation
muscular activity
fluctuation of muscular activity (EMG)
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start19 Jan 2021
- Primary completion1 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb FractureStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675372
- Sponsor's protocol ID
- IRB-XWAD-202008-12
- Status last verified
- Aug 2021
- First submitted
- 11 Dec 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia
- ClinicalTrials.gov ID
- NCT04675372
- Acronym / sponsor ID
- IRB-XWAD-202008-12
- Conditions
- Lower Limb Fracture, Nerve Block
- Keywords
- Dexmedetomidine, nociceptive index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 19 Dec 2020 (actual)
- 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.
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.
Detailed description
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: DexmedetomidineDexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX) |
| Group 2 | Active comparator | Drug: MidazolamMidazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged from 18 to 80 years old
- American Association of anesthesiologists (ASA) grade Ⅱ ~ IV
- body mass index (BMI) 18.5-40
- planning undergoing peripheral nerve block
Key exclusion criteria (7 listed)
- incomplete effect of nerve block
- Alzheimer's disease
- implanted cardiac pacemakers
- mental illness
- epilepsy
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 group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion | Drug | Group 1 |
| MidazolamMidazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam | Drug | Group 2 |
Primary outcome
nociceptive index
Time frame: During operation
qNOX reached target 80 during drug infusion（qNOX<80 Adequate；qNOX>80 unadequate）
5 secondary outcomes
hypoxemia
Time frame: During operation
systolic blood pressure
Time frame: During operation
heart rate
Time frame: During operation
diastolic blood pressure
Time frame: During operation
muscular activity
Time frame: During operation
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 Aug 2021.
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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 Midazolam in people with Lower Limb Fracture and Nerve Block, run by China International Neuroscience Institution at 1 site in China.
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 4 inclusion and 7 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 Aug 2021. 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 China. 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?
nociceptive index (time frame: During operation). 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 Aug 2021.