Recording of Intraoperative Spinal Cord Stimulation and Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
Disqualifiers
none
Trial design
Design model
Single group
Treatments tested in this trial
epidural electrical stimulation
DeviceElectrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Electrical Stimulation groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in respiratory frequency
Increase or decrease in respiratory frequency of 20% during or after stimulation
Time frame
During intraoperative surgery during stimulation and within 2 minutes after stimulation2
Change in respiratory tidal volume
Increase or decrease in respiratory tidal volume of 20% during or after stimulation
Time frame
During intraoperative surgery during stimulation and within 2 minutes after stimulationSecondary outcomes
1
Change in heart rate
Increase or decrease in heart rate of 20% during or after stimulation
Time frame
During intraoperative surgery during stimulation and within 2 minutes after stimulation2
Change in blood pressure
Increase or decrease in blood pressure of 20% during or after stimulation
Time frame
During intraoperative surgery during stimulation and within 2 minutes after stimulationSponsors and contacts
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Source ClinicalTrials.gov