Dexmedetomidine on Intraoperative Somatosensory and Motor Evoked Potential Monitoring During Neurosurgery in Pediatric Patients

Brain Tumor Clinical Trial

Official title:

Measuring the Effects of Dexmedetomidine on Somatosensory Evoked and Muscular Evoked Potential During Neurosurgery in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512147
• Other study ID #: IRB00007472
• Status: Completed
• Phase: N/A
• First received: December 19, 2011
• Last updated: April 3, 2018
• Start date: December 2011
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to know if using the study drug dexmedetomidine will improve nerve wave readings during neurosurgery. These readings are done many times during surgery while the patient is asleep. The readings look at how nerves are working and let the operating team know if nerves are hurt during surgery. If the readings tell that nerves are not working correctly, the surgeons can help while changing the way of operating.

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.

Description:

Somatosensory evoked potential (SSEP) and motor evoked potential (MEP) have become an integral component in intraoperative care of patients and have resulted in a high degree of sensitivity in predicting neurologic outcomes. According to Padberg, Nuwer and Ecker ,SSEP and MEP monitoring allows surgical interventions to occur early and thus decreases the incidence of postoperative neurologic deficits.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Pediatric patients between 2 and 12 years old

• Undergoing neurosurgery and

• Requiring SSEP/ MEP measurements

Exclusion Criteria:

• Patients younger than 2 and older than 12 years

• Patients with known bradyarrhythmias

• Patients with severe liver disease

• Conditions that may alter reading, e.g. neuromuscular diseases

Related Conditions & MeSH terms

• Brain Tumor
• Cranio Cervical Compression
• Tethered Spinal Cord

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Ohsu - Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. — View Citation

Bloom M, Beric A, Bekker A. Dexmedetomidine infusion and somatosensory evoked potentials. J Neurosurg Anesthesiol. 2001 Oct;13(4):320-2. — View Citation

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. — View Citation

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. — View Citation

Møller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant improvement of MEP and SSEP readings during neurosurgery for pediatric patients while using dexmedetomidine as an adjunct to general anesthesia and therefore improvement in clinical decision making.	Changes in latency and amplitude of SSEP and changes in amplitude and morphology of MEP while using different anesthetic combinations including isoflurane, propofol and dexmedetomidine.	30 - 60 minutes of SSEP and MEP measurements intraoperatively