Idiopathic Scoliosis
Conditions
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.
Interventions
DRUGpropofol
Propofol adjusted to maintain the bispectral index at 40-60.
DRUGDesflurane
Desflurane adjusted to maintain the bispectral index at 40-60.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with idiopathic scoliosis.
Exclusion criteria
* Patients with neuromuscular scoliosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Intravenous Anesthesia (TIVA) propofol: Propofol adjusted to maintain the bispectral index at 40-60. | 15 |
| Inhaled Anesthesia Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Inhaled Anesthesia | Total Intravenous Anesthesia (TIVA) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 15.4 years STANDARD_DEVIATION 2.4 | 14.5 years STANDARD_DEVIATION 2.1 | 14.9 years STANDARD_DEVIATION 2.2 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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).
Time frame: at time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Amplitude Required to Elicit the MEP | 307 milliamperes | Standard Deviation 72 |
| Inhaled Anesthesia | Amplitude Required to Elicit the MEP | 417 milliamperes | Standard Deviation 82 |
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.
Time frame: day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Amplitude of the SSEPs | 0.83 microvolt | Standard Deviation 0.4 |
| Inhaled Anesthesia | Amplitude of the SSEPs | 0.84 microvolt | Standard Deviation 0.25 |
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.
Time frame: day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Latency of the SSEP's | 27.6 milliseconds | Standard Deviation 1.9 |
| Inhaled Anesthesia | Latency of the SSEP's | 28.2 milliseconds | Standard Deviation 2 |