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NCT05356286 Clinical Trial

Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Spondylosis Clinical Trial

Official title:
Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05356286
Other study ID # 11-000043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2011
Est. completion date January 22, 2027

Study information
Verified date April 2022
Source University of California, Los Angeles
Contact Daniel Lu, MD
Phone 310/825/4321
Email dclu@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date January 22, 2027
Est. primary completion date January 22, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized. Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• epidural electrical stimulation
Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.

Locations
Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in respiratory frequency Increase or decrease in respiratory frequency of 20% during or after stimulation During intraoperative surgery during stimulation and within 2 minutes after stimulation
Primary Change in respiratory tidal volume Increase or decrease in respiratory tidal volume of 20% during or after stimulation During intraoperative surgery during stimulation and within 2 minutes after stimulation
Secondary Change in heart rate Increase or decrease in heart rate of 20% during or after stimulation During intraoperative surgery during stimulation and within 2 minutes after stimulation
Secondary Change in blood pressure Increase or decrease in blood pressure of 20% during or after stimulation During intraoperative surgery during stimulation and within 2 minutes after stimulation
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