Recording of Intraoperative Spinal Cord Stimulation and Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: epidural electrical stimulation.
- Who it may be relevant to
- Registry conditions: Cervical Stenosis, Disk, Herniated, Spondylosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device epidural electrical stimulation
Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.
Primary outcome measures
- Change in respiratory frequency [Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation]
- Change in respiratory tidal volume [Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation]
Secondary outcome measures (2)
- Change in heart rate [Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation]
- Change in blood pressure [Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation]
Eligibility criteria
Inclusion criteria
- Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, Los Angeles — Los Angeles
Identifiers
NCT: NCT05356286 · 11-000043