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Trial record 9 of 39 for:    "Spinal Disease" | "Benzocaine"

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

Tracking Information
First Submitted Date  ICMJE March 7, 2012
First Posted Date  ICMJE March 9, 2012
Results First Submitted Date  ICMJE February 4, 2015
Results First Posted Date  ICMJE February 26, 2015
Last Update Posted Date February 26, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
Feasibility of monitoring MEP's and SSEP's [ Time Frame: at time of surgery ]
Determine the feasibility of monitoring MEP's and SSEP's during anesthesia with an inhalational anesthetic.
Change History Complete list of historical versions of study NCT01549873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
  • Amplitude required to elicit the MEP [ Time Frame: day 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).
  • Amplitude of the SSEPs [ Time Frame: day of surgery ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients
Official Title  ICMJE Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Idiopathic Scoliosis
Intervention  ICMJE
  • Drug: propofol
    Propofol adjusted to maintain the bispectral index at 40-60.
    Other Name: Diprivan
  • Drug: Desflurane
    Desflurane adjusted to maintain the bispectral index at 40-60.
    Other Name: Suprane
Study Arms  ICMJE
  • Active Comparator: Total intravenous anesthesia (TIVA)
    Intervention: Drug: propofol
  • Active Comparator: Inhaled anesthesia
    Intervention: Drug: Desflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2012)
20
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with idiopathic scoliosis.

Exclusion Criteria:

  • Patients with neuromuscular scoliosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01549873
Other Study ID Numbers  ICMJE IRB11-00727
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph D. Tobias, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP