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Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01549873
First received: March 7, 2012
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Idiopathic Scoliosis
 Drug: propofol
Drug: Desflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Feasibility of monitoring MEP's and SSEP's [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]
    Determine the feasibility of monitoring MEP's and SSEP's during anesthesia with an inhalational anesthetic.


Secondary Outcome Measures:
  • Amplitude required to elicit the MEP [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    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).

  • Amplitude of the SSEP's [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    Compare the data obtained from neuromonitoring including the amplitude of the SSEP's from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving TIVA.

  • Latency of the SSEP's [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    Compare the data obtained from neuromonitoring including the latency of the SSEP's from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving TIVA.


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with idiopathic scoliosis.

Exclusion Criteria:

  • Patients with neuromuscular scoliosis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549873

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
  More Information

No publications provided

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
Study First Received: March 7, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Propofol
Desflurane
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 19, 2013