Dexmedetomidine on Intraoperative Somatosensory and Motor Evoked Potential Monitoring During Neurosurgery in Pediatric Patients
NCT ID: NCT01512147
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-12-31
2018-04-30
Brief Summary
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The study drug will be used in addition to the general anesthesia that a patient is given. The nerve readings that the investigators get while using the study drug will be compared with nerve readings that the investigators get while not using the study drug.
The study hypothesis is that dexmedetomidine does not change nerve readings.
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Detailed Description
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These measurements are done during surgery under general anesthesia and it is known that anesthetic agents have a dose-dependent adverse effect on the ability to record evoked potential responses. All anesthesia agents seem to interfere with the measurements especially in higher doses.
In 1999, dexmedetomidine, a highly specific and selective alpha-2-adrenergic agonist with sedative, anxiolytic and analgesic effects, got FDA approved for adult patients for sedation. Since then, it has also been widely used off-label in various settings; it is described as a successful adjunct for surgical procedures in adolescents and adult populations where SSEP/ MEP monitoring is beneficial. Several small and retrospective studies have shown that dexmedetomidine does not appear to interfere with neurophysiological monitoring when used in FDA approved doses.
In pediatric patients, dexmedetomidine is also used off-label and has been shown to be beneficial. In fact, at Doernbecher Childen's Hospital, the use of dexmedetomidine has become a standard in pediatric procedures involving SSEP and MEP measurements. To the best of our knowledge, prospective studies in pediatric patients with SSEP monitoring while using dexmedetomidine have not been completed.
If dexmedetomidine does not interfere the SSEP/MEP reading, it might be an advantageous adjunct to use in these settings. Propofol has a small risk of a serious side effect called propofol infusion syndrome. Propofol infusion syndrome is potentially life threatening, with the development of a profound lactate acidosis. It is seen when large doses of propofol (usually from a prolonged infusion) are given in the pediatric population.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Isoflurane, Propofol, Dexmedetomidine
Our trial will examine the changes in latency and amplitude of SSEP and changes in amplitude and morphology of MEP while using different anesthetic combinations including isoflurane, proposal and dexmedetomidine. Monitoring teams will document any changes throughout the surgery and communicate with the team about those changes. The design of the study will be a prospective AB design.
Isoflurane, Propofol, Dexmedetomidine
We will include following general anesthesia techniques:
Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250 mcg/kg/min, Isoflurane 0.6% expiratory With this general anesthesia technique we will do our first SSEP/MEP measurements after 30 minutes.
After 30 minutes we will stop isoflurane and will wash out the inhalational anesthetic with high flow air/oxygen and provide:
Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250mcg/kg/min. This technique will be held for 30 minutes. SSEP/ MEP measurements will be done after 30 minutes.
After the measurements dexmedetomidine will be added with a loading dose of 0.5 mcg/kg over 10 minutes and continuous infusion of 0.5 mcg/kg/hr for 30 minutes.
Fentanyl 1 -2 mcg/kg/hr, Propofol 100 - 250mcg/kg/min, Dexmedetomidine 0.5 mcg/kg/hr.
Interventions
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Isoflurane, Propofol, Dexmedetomidine
We will include following general anesthesia techniques:
Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250 mcg/kg/min, Isoflurane 0.6% expiratory With this general anesthesia technique we will do our first SSEP/MEP measurements after 30 minutes.
After 30 minutes we will stop isoflurane and will wash out the inhalational anesthetic with high flow air/oxygen and provide:
Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250mcg/kg/min. This technique will be held for 30 minutes. SSEP/ MEP measurements will be done after 30 minutes.
After the measurements dexmedetomidine will be added with a loading dose of 0.5 mcg/kg over 10 minutes and continuous infusion of 0.5 mcg/kg/hr for 30 minutes.
Fentanyl 1 -2 mcg/kg/hr, Propofol 100 - 250mcg/kg/min, Dexmedetomidine 0.5 mcg/kg/hr.
Eligibility Criteria
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Inclusion Criteria
* Undergoing neurosurgery and
* Requiring SSEP/ MEP measurements
Exclusion Criteria
* Patients with known bradyarrhythmias
* Patients with severe liver disease
* Conditions that may alter reading, e.g. neuromuscular diseases
2 Years
12 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Heike Gries, MD, PhD
Assistant Professor, Pediatric Anesthesiology
Principal Investigators
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Heike Gries, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Ohsu - Oregon Health and Science University
Portland, Oregon, United States
Countries
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References
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Padberg AM, Wilson-Holden TJ, Lenke LG, Bridwell KH. Somatosensory- and motor-evoked potential monitoring without a wake-up test during idiopathic scoliosis surgery. An accepted standard of care. Spine (Phila Pa 1976). 1998 Jun 15;23(12):1392-400. doi: 10.1097/00007632-199806150-00018.
Ecker ML, Dormans JP, Schwartz DM, Drummond DS, Bulman WA. Efficacy of spinal cord monitoring in scoliosis surgery in patients with cerebral palsy. J Spinal Disord. 1996 Apr;9(2):159-64.
Nuwer MR, Dawson EG, Carlson LG, Kanim LE, Sherman JE. Somatosensory evoked potential spinal cord monitoring reduces neurologic deficits after scoliosis surgery: results of a large multicenter survey. Electroencephalogr Clin Neurophysiol. 1995 Jan;96(1):6-11. doi: 10.1016/0013-4694(94)00235-d.
Thuet ED, Padberg AM, Raynor BL, Bridwell KH, Riew KD, Taylor BA, Lenke LG. Increased risk of postoperative neurologic deficit for spinal surgery patients with unobtainable intraoperative evoked potential data. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2094-103. doi: 10.1097/01.brs.0000178845.61747.6a.
Banoub M, Tetzlaff JE, Schubert A. Pharmacologic and physiologic influences affecting sensory evoked potentials: implications for perioperative monitoring. Anesthesiology. 2003 Sep;99(3):716-37. doi: 10.1097/00000542-200309000-00029. No abstract available.
Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.
Tobias JD, Goble TJ, Bates G, Anderson JT, Hoernschemeyer DG. Effects of dexmedetomidine on intraoperative motor and somatosensory evoked potential monitoring during spinal surgery in adolescents. Paediatr Anaesth. 2008 Nov;18(11):1082-8. doi: 10.1111/j.1460-9592.2008.02733.x.
Bala E, Sessler DI, Nair DR, McLain R, Dalton JE, Farag E. Motor and somatosensory evoked potentials are well maintained in patients given dexmedetomidine during spine surgery. Anesthesiology. 2008 Sep;109(3):417-25. doi: 10.1097/ALN.0b013e318182a467.
Anschel DJ, Aherne A, Soto RG, Carrion W, Hoegerl C, Nori P, Seidman PA. Successful intraoperative spinal cord monitoring during scoliosis surgery using a total intravenous anesthetic regimen including dexmedetomidine. J Clin Neurophysiol. 2008 Feb;25(1):56-61. doi: 10.1097/WNP.0b013e318163cca6.
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.
Bloom M, Beric A, Bekker A. Dexmedetomidine infusion and somatosensory evoked potentials. J Neurosurg Anesthesiol. 2001 Oct;13(4):320-2. doi: 10.1097/00008506-200110000-00007.
Moller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.
Other Identifiers
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IRB00007472
Identifier Type: -
Identifier Source: org_study_id
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