Back to resultsAnesthesia During Neurophysiologic Monitoring in Scoliosis Patients
Primary Purpose
Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
propofol
Desflurane
Sponsored by
About this trial
This is an interventional supportive care trial for Idiopathic Scoliosis
Eligibility Criteria
Inclusion Criteria:
- Patients with idiopathic scoliosis.
Exclusion Criteria:
- Patients with neuromuscular scoliosis.
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Total intravenous anesthesia (TIVA)
Inhaled anesthesia
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01549873
First Posted
March 7, 2012
Last Updated
February 24, 2015
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01549873
Brief Title
Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients
Official Title
Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total intravenous anesthesia (TIVA)
Arm Type
Active Comparator
Arm Title
Inhaled anesthesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Propofol adjusted to maintain the bispectral index at 40-60.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Suprane
Intervention Description
Desflurane adjusted to maintain the bispectral index at 40-60.
Primary Outcome Measure Information:
Title
Amplitude Required to Elicit the MEP
Description
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).
Time Frame
at time of surgery
Secondary Outcome Measure Information:
Title
Amplitude of the SSEPs
Description
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.
Time Frame
day of surgery
Title
Latency of the SSEP's
Description
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.
Time Frame
day of surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with idiopathic scoliosis.
Exclusion Criteria:
Patients with neuromuscular scoliosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D Tobias, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients
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