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Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

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ClinicalTrials.gov Identifier: NCT01549873
Recruitment Status : Completed
First Posted : March 9, 2012
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Scoliosis Drug: propofol Drug: Desflurane Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia
Study Start Date : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Total intravenous anesthesia (TIVA) Drug: propofol
Propofol adjusted to maintain the bispectral index at 40-60.
Other Name: Diprivan
Active Comparator: Inhaled anesthesia Drug: Desflurane
Desflurane adjusted to maintain the bispectral index at 40-60.
Other Name: Suprane


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Amplitude of the SSEPs [ Time Frame: day of surgery ]
    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.

  2. Latency of the SSEP's [ Time Frame: day of surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with idiopathic scoliosis.

Exclusion Criteria:

  • Patients with neuromuscular scoliosis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549873


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
More Information
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Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01549873     History of Changes
Other Study ID Numbers: IRB11-00727
First Posted: March 9, 2012    Key Record Dates
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Spinal Diseases
Scoliosis
Spinal Curvatures
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Propofol
 Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation