ScoliosisPhase 1NCT00671931
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
A Phase 1 study testing low dexmedetomidine, low propofol, high dexmedetomidine, low propofol and Dexmedetomidine in people with Scoliosis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- low dexmedetomidine, low propofol, high dexmedetomidine, low propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jan 2009
- Phase
- Phase 1
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must be 10 to 25 years of age
- Diagnosis of idiopathic scoliosis is established
- Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate
- American society of Anesthesiology physical status one/two
- Patients scheduled for posterior spinal fusion only
Who cannot join
- • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities
- Patients with allergy to, or contraindication for the drugs or techniques used in the study
- Morbid obesity (Body mass index higher than 40)
- History of malignant hyperthermia
- Patient with severe cardiopulmonary disease (pulmonary hypertension, cardiomyopathy, mechanical ventilation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinati Children Medical Center
Cincinnati, Ohio, 45229
About this study
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.
Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.
- Conditions
- Scoliosis
- Being tested
- low dexmedetomidine, low propofol, high dexmedetomidine, low propofol, Dexmedetomidine, Dexmedetomidin
- Keywords
- dexmedetomidine, neuromonitoring, spine procedures, safe dose, 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring, 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring, 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dexmedetomidine, low propofolDrug
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
high dexmedetomidine, low propofolDrug
Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
DexmedetomidineDrug
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
DexmedetomidinDrug
Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
DexmedetomidineDrug
Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Dexmedetomidine low infusion, Propofol low infusion Receives: Drug: low dexmedetomidine, low propofol |
| II | Active comparator | Dexmedetomidine high infusion, Propofol low infusion Receives: Drug: high dexmedetomidine, low propofol |
| IV | Active comparator | Dexmedetomidine high infusion, Propofol high infusion Receives: Drug: Dexmedetomidin |
| V | Active comparator | Dexmedetomidine intermediate infusion, Propofol intermediate infusion Receives: Drug: Dexmedetomidine |
| III | Active comparator | Dexmedetomidine low infusion, Propofol high infusion Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Evoked Potential Amplitude
The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.
Measured: baseline, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2009
- Study completionJan 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 1
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Mahmoud, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671931
- Sponsor's protocol ID
- 06-09-12
- Status last verified
- Aug 2013
- First submitted
- 30 Apr 2008
- Last updated
- 23 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mahmoud M, Sadhasivam S, Salisbury S, Nick TG, Schnell B, Sestokas AK, Wiggins C, Samuels P, Kabalin T, McAuliffe J. Susceptibility of transcranial electric motor-evoked potentials to varying targeted blood levels of dexmedetomidine during spine surgery. Anesthesiology. 2010 Jun;112(6):1364-73. doi: 10.1097/ALN.0b013e3181d74f55.
PubMed 20460997
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
- ClinicalTrials.gov ID
- NCT00671931
- Acronym / sponsor ID
- 06-09-12
- Conditions
- Scoliosis
- Keywords
- dexmedetomidine, neuromonitoring, spine procedures, safe dose, 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring, 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring, 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Posted 23 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.
Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: low dexmedetomidine, low propofolDexmedetomidine low infusion, Propofol low infusion |
| II | Active comparator | Drug: high dexmedetomidine, low propofolDexmedetomidine high infusion, Propofol low infusion |
| IV | Active comparator | Drug: DexmedetomidinDexmedetomidine high infusion, Propofol high infusion |
| V | Active comparator | Drug: DexmedetomidineDexmedetomidine intermediate infusion, Propofol intermediate infusion |
| III | Active comparator | Drug: DexmedetomidineDexmedetomidine low infusion, Propofol high infusion |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects must be 10 to 25 years of age
- Diagnosis of idiopathic scoliosis is established
- Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate
- American society of Anesthesiology physical status one/two
- Patients scheduled for posterior spinal fusion only
Key exclusion criteria (5 listed)
- • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities
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 |
|---|---|---|
| low dexmedetomidine, low propofolDexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M | Drug | I |
| high dexmedetomidine, low propofolDexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M | Drug | II |
| DexmedetomidineDexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M | Drug | III |
| DexmedetomidinDexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M | Drug | IV |
| DexmedetomidineDexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min | Drug | V |
Primary outcome
Motor Evoked Potential Amplitude
Time frame: baseline, 30 minutes
The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20460997Mahmoud M, Sadhasivam S, Salisbury S, Nick TG, Schnell B, Sestokas AK, Wiggins C, Samuels P, Kabalin T, McAuliffe J. Susceptibility of transcranial electric motor-evoked potentials to varying targeted blood levels of dexmedetomidine during spine surgery. Anesthesiology. 2010 Jun;112(6):1364-73. doi: 10.1097/ALN.0b013e3181d74f55.
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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.
Mohamed Mahmoud, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing low dexmedetomidine, low propofol, high dexmedetomidine, low propofol and Dexmedetomidine in people with Scoliosis, run by Children's Hospital Medical Center, Cincinnati 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 5 inclusion and 5 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 23 Aug 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 Aug 2013). 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?
Motor Evoked Potential Amplitude (time frame: baseline, 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671931, which also lists 1 linked publication.
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 23 Aug 2013.