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Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

Sponsor
Nationwide Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01549873
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
17
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Total intravenous anesthesia (TIVA)

Drug: propofol
Propofol adjusted to maintain the bispectral index at 40-60.
Other Names:
  • Diprivan

    		•
    Active Comparator: Inhaled anesthesia

    Drug: Desflurane
    Desflurane adjusted to maintain the bispectral index at 40-60.
    Other Names:
  • Suprane

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Amplitude Required to Elicit the MEP [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 [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 [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

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with idiopathic scoliosis.
    Exclusion Criteria:
    • Patients with neuromuscular scoliosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01549873
    Other Study ID Numbers:
    • IRB11-00727
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Feb 26, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Scoliosis
    Propofol
    Desflurane

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Arm/Group Description propofol: Propofol adjusted to maintain the bispectral index at 40-60. Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
    Period Title: Overall Study
    STARTED 15 15
    COMPLETED 15 14
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia Total
    Arm/Group Description propofol: Propofol adjusted to maintain the bispectral index at 40-60. Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60. Total of all reporting groups
    Overall Participants 15 15 30
    Age (Count of Participants)
    <=18 years
    14
    93.3%
    13
    86.7%
    27
    90%
    Between 18 and 65 years
    1
    6.7%
    2
    13.3%
    3
    10%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    14.5
    (2.1)
    15.4
    (2.4)
    14.9
    (2.2)
    Sex: Female, Male (Count of Participants)
    Female
    14
    93.3%
    14
    93.3%
    28
    93.3%
    Male
    1
    6.7%
    1
    6.7%
    2
    6.7%
    Region of Enrollment (participants) [Number]
    United States
    15
    100%
    15
    100%
    30
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Arm/Group Description propofol: Propofol adjusted to maintain the bispectral index at 40-60. Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
    Measure Participants 15 14
    Mean (Standard Deviation) [milliamperes]
    307
    (72)
    417
    (82)
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Arm/Group Description propofol: Propofol adjusted to maintain the bispectral index at 40-60. Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
    Measure Participants 15 14
    Mean (Standard Deviation) [microvolt]
    0.83
    (0.4)
    0.84
    (0.25)
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Arm/Group Description propofol: Propofol adjusted to maintain the bispectral index at 40-60. Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
    Measure Participants 15 14
    Mean (Standard Deviation) [milliseconds]
    27.6
    (1.9)
    28.2
    (2)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Arm/Group Description propofol: Propofol adjusted to maintain the bispectral index at 40-60. Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
    All Cause Mortality
    Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title David Martin, MD
    Organization Nationwide Children's Hospital
    Phone 614-722-4200
    Email David.Martin@nationwidechildrens.org
    Responsible Party:
    Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01549873
    Other Study ID Numbers:
    • IRB11-00727
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Feb 26, 2015
    Last Verified:
    Feb 1, 2015