Spinal FusionPhase 4NCT03378973
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
A Phase 4 study testing Dexmedetomidine in people with Spinal Fusion, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 17 Oct 2019
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring
Who cannot join
- Allergy to dexmedetomidine, propofol
- Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
- Hepatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: The Effects of Dexmedetomidine Dose on Motor Evoked Potentials During Spine Surgery: A Randomized, Single-blind Trial
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery
Read the detailed description
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery
- Conditions
- Spinal Fusion
- Being tested
- Dexmedetomidine
- Keywords
- motor evoked potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
| Study group | Role | What they receive |
|---|---|---|
| High dose dexmedetomidine | Experimental | Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min Receives: Drug: Dexmedetomidine |
| Low dose dexmedetomidine | Active comparator | Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients With Monitorable of Motor Evoked Potentials
Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.
Measured: During a single surgery for the duration of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start28 Nov 2018
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Why it stopped: No longer clinically relevant
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 Spinal FusionStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Emerson, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378973
- Sponsor's protocol ID
- 2017-1304
- Status last verified
- Apr 2020
- First submitted
- 12 Dec 2017
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine Dose on Motor Evoked Potentials During Spine Surgery: A Randomized, Single-blind Trial
- ClinicalTrials.gov ID
- NCT03378973
- Acronym / sponsor ID
- 2017-1304
- Conditions
- Spinal Fusion
- Keywords
- motor evoked potentials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer clinically relevant
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 28 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery
Detailed description
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose dexmedetomidine | Experimental | Drug: DexmedetomidinePatients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min |
| Low dose dexmedetomidine | Active comparator | Drug: DexmedetomidinePatients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring
Key exclusion criteria (3 listed)
- Allergy to dexmedetomidine, propofol
- Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
- Hepatic disease
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: PrecedexPatients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. | Drug | High dose dexmedetomidine, Low dose dexmedetomidine |
Primary outcome
Percent of Patients With Monitorable of Motor Evoked Potentials
Time frame: During a single surgery for the duration of the operation
Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- 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.
Ronald Emerson, MD principal investigator
Hospital for Special Surgery, New York
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 in people with Spinal Fusion, run by Hospital for Special Surgery, New York at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 28 Apr 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2020). 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?
Percent of Patients With Monitorable of Motor Evoked Potentials (time frame: During a single surgery for the duration of the 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 28 Apr 2020.