Effect of Ketamine on Intraoperative Motor Evoked Potentials
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to learn about the effect of ketamine on intraoperative motor evoked potentials in adult patients undergoing thoracolumbar spinal fusions. Participants will undergo a standard anesthetic. In addition to the standard anesthetic, the patients will be administered increasing doses of ketamine with motor-evoked potentials being measured at each dose, to assess any impacts.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
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• Adult patients (\>18 years of age) undergoing posterior spinal fusions.
Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Marc Buren, MD
marc.buren@ucsf.edu
4154768369
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 20
Treatments
Experimental: Ketamine
All subjects will be in a single arm. Patients will serve as their own control.~Patients will receive general anesthesia in the usual fashion for the indicated procedures. This anesthetic will be standardized between patients. All patients participating in the study will have neuromonitoring as part of their spine surgery as standard care. Baseline motor-evoked potential data will then be collected. Then study drug Ketamine will be administered as following:~* Step 1: 0.1 mg/kg bolus over 30 sec followed by infusion of 3mcg/kg/min (0.18 mg/kg/hr)~* Step 2: 0.3 mg/kg bolus over 30 sec followed by infusion of 15mcg/kg/min (0.9mg/kg/hr)~* Step 3: 0.85 mg/kg bolus over 30 sec followed by infusion at 50mcg/kg/min (3mg/kg/hr)~Motor Evoked Potentials will be collected for 5 times at minutes 2, 4, 6, 8, 10 after drug step.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco