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

Primary Purpose

Tethered Spinal Cord, Brain Tumor, Cranio Cervical Compression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isoflurane, Propofol, Dexmedetomidine
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tethered Spinal Cord focused on measuring SSEP measurements, MEP measurements, Pediatric Patients, Neurosurgery, General Anesthesia

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohsu - Oregon Health and Science University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Isoflurane, Propofol, Dexmedetomidine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2011
Last Updated
April 3, 2018
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01512147
Brief Title
Dexmedetomidine on Intraoperative Somatosensory and Motor Evoked Potential Monitoring During Neurosurgery in Pediatric Patients
Official Title
Measuring the Effects of Dexmedetomidine on Somatosensory Evoked and Muscular Evoked Potential During Neurosurgery in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tethered Spinal Cord, Brain Tumor, Cranio Cervical Compression
Keywords
SSEP measurements, MEP measurements, Pediatric Patients, Neurosurgery, General Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isoflurane, Propofol, Dexmedetomidine
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Isoflurane, Propofol, Dexmedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 - 60 minutes of SSEP and MEP measurements intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Gries, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohsu - Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9654631
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. doi: 10.1097/00007632-199806150-00018.
Results Reference
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PubMed Identifier
8793785
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.
Results Reference
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PubMed Identifier
7530190
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. doi: 10.1016/0013-4694(94)00235-d.
Results Reference
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PubMed Identifier
16166902
Citation
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Results Reference
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PubMed Identifier
12960558
Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Dexmedetomidine on Intraoperative Somatosensory and Motor Evoked Potential Monitoring During Neurosurgery in Pediatric Patients

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