Idiopathic ScoliosisNCT01549873
Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients
A study testing propofol and Desflurane in people with Idiopathic Scoliosis, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- propofol and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with idiopathic scoliosis.
Who cannot join
- Patients with neuromuscular scoliosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia
When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.
- Conditions
- Idiopathic Scoliosis
- Being tested
- propofol, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Diprivan
Propofol adjusted to maintain the bispectral index at 40-60.
DesfluraneDrug
Also called Suprane
Desflurane adjusted to maintain the bispectral index at 40-60.
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia (TIVA) | Active comparator | Not described Receives: Drug: propofol |
| Inhaled anesthesia | Active comparator | Not described Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude Required to Elicit the MEP
Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).
Measured: at time of surgery
Secondary outcomes (2)
Amplitude of the SSEPs
SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. The amplitude is the voltage of the electrical stimulation recorded.
Measured: day of surgery
Latency of the SSEP's
SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. Latency is the time interval between the stimulation and response.
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionJun 2013
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 Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549873
- Sponsor's protocol ID
- IRB11-00727
- Status last verified
- Feb 2015
- First submitted
- 7 Mar 2012
- Last updated
- 26 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT01549873
- Acronym / sponsor ID
- IRB11-00727
- Conditions
- Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia (TIVA) | Active comparator | Drug: propofol |
| Inhaled anesthesia | Active comparator | Drug: Desflurane |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with idiopathic scoliosis.
Key exclusion criteria (1 listed)
- Patients with neuromuscular scoliosis.
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 |
|---|---|---|
| propofolAlso: DiprivanPropofol adjusted to maintain the bispectral index at 40-60. | Drug | Total intravenous anesthesia (TIVA) |
| DesfluraneAlso: SupraneDesflurane adjusted to maintain the bispectral index at 40-60. | Drug | Inhaled anesthesia |
Primary outcome
Amplitude Required to Elicit the MEP
Time frame: at time of surgery
Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).
2 secondary outcomes
Amplitude of the SSEPs
Time frame: day of surgery
Latency of the SSEP's
Time frame: day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph D Tobias, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and Desflurane in people with Idiopathic Scoliosis, run by Nationwide Children's Hospital 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 1 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 26 Feb 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2015). 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?
Amplitude Required to Elicit the MEP (time frame: at time of surgery). 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 26 Feb 2015.