Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 39 for:    "Spinal Disease" | "Benzocaine"

Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Idiopathic Scoliosis
Interventions Drug: propofol
Drug: Desflurane
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Hide 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
Reason Not Completed
Physician Decision             0             1
Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia Total
Hide 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 Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
14
  93.3%
13
  86.7%
27
  90.0%
Between 18 and 65 years
1
   6.7%
2
  13.3%
3
  10.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
14.5  (2.1) 15.4  (2.4) 14.9  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
14
  93.3%
14
  93.3%
28
  93.3%
Male
1
   6.7%
1
   6.7%
2
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Amplitude Required to Elicit the MEP
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Hide 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.
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: milliamperes
307  (72) 417  (82)
2.Secondary Outcome
Title Amplitude of the SSEPs
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Hide 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.
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: microvolt
0.83  (0.4) 0.84  (0.25)
3.Secondary Outcome
Title Latency of the SSEP’s
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Hide 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.
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: milliseconds
27.6  (1.9) 28.2  (2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Intravenous Anesthesia (TIVA) Inhaled Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Martin, MD
Organization: Nationwide Children's Hospital
Phone: 614-722-4200
EMail: David.Martin@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01549873     History of Changes
Other Study ID Numbers: IRB11-00727
First Submitted: March 7, 2012
First Posted: March 9, 2012
Results First Submitted: February 4, 2015
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015