An interventional study of propofol and Desflurane in Idiopathic Scoliosis, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Supportive care
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.
594 studies on the registry are indexed under Scoliosis; 138 are open to participants now.
This study's enrollment of 30 is below the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: propofol
Drug: Desflurane
Propofol adjusted to maintain the bispectral index at 40-60.
Also known as: Diprivan
Desflurane adjusted to maintain the bispectral index at 40-60.
Also known as: Suprane
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
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
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
| Milestone | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 14 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
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).
| milliamperes | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia |
|---|---|---|
| Amplitude Required to Elicit the MEP | 307 ± 72 | 417 ± 82 |
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.
| microvolt | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia |
|---|---|---|
| Amplitude of the SSEPs | 0.83 ± 0.4 | 0.84 ± 0.25 |
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.
| milliseconds | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia |
|---|---|---|
| Latency of the SSEP's | 27.6 ± 1.9 | 28.2 ± 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Intravenous Anesthesia (TIVA) | — | 0/15 (0%) | 0/15 (0%) |
| Inhaled Anesthesia | — | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia | Total |
|---|---|---|---|
| <=18 years | 14 | 13 | 27 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia | Total |
|---|---|---|---|
| Mean | 14.5 ± 2.1 | 15.4 ± 2.4 | 14.9 ± 2.2 |
| Sex: Female, Male(Participants) | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia | Total |
|---|---|---|---|
| Female | 14 | 14 | 28 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | Total Intravenous Anesthesia (TIVA) | Inhaled Anesthesia | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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