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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total intravenous anesthesia (TIVA) | Active Comparator |
| |
| Inhaled anesthesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | Propofol adjusted to maintain the bispectral index at 40-60. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude Required to Elicit the MEP | 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). | at time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of the SSEPs | 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. | day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Intravenous Anesthesia (TIVA) | propofol: Propofol adjusted to maintain the bispectral index at 40-60. |
| FG001 | Inhaled Anesthesia | Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Intravenous Anesthesia (TIVA) | propofol: Propofol adjusted to maintain the bispectral index at 40-60. |
| BG001 | Inhaled Anesthesia | Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amplitude Required to Elicit the MEP | 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). | Posted | Mean | Standard Deviation | milliamperes | at time of surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Intravenous Anesthesia (TIVA) | propofol: Propofol adjusted to maintain the bispectral index at 40-60. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Martin, MD | Nationwide Children's Hospital | 614-722-4200 | David.Martin@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Desflurane | Drug | Desflurane adjusted to maintain the bispectral index at 40-60. |
|
|
| Latency of the SSEP's | 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. | day of surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Amplitude of the SSEPs | 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. | Posted | Mean | Standard Deviation | microvolt | day of surgery |
|
|
|
| Secondary | Latency of the SSEP's | 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. | Posted | Mean | Standard Deviation | milliseconds | day of surgery |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Inhaled Anesthesia | Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60. | 0 | 15 | 0 | 15 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |