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Ketamine for Spinal Fusion
Phase 3
Recruiting
Led By Marc Buren, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients (>18 years of age) undergoing posterior spinal fusions.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial will study how ketamine affects spinal fusion surgery, and how it impacts the body's response to anesthesia.
Who is the study for?
This trial is for adults over 18 years old who are having posterior spinal fusions due to conditions like spinal stenosis or tumors. It's not suitable for those who may have health issues that aren't mentioned but would prevent them from safely receiving ketamine.Check my eligibility
What is being tested?
The study is testing how different doses of ketamine, given alongside standard anesthesia during surgery, affect the motor signals in patients' muscles (motor evoked potentials) when they're getting thoracolumbar spinal fusion surgery.See study design
What are the potential side effects?
Ketamine can cause side effects such as changes in blood pressure and heart rate, disorientation, hallucinations, nausea, vomiting, and possibly an increase or decrease in muscle responses during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in motor evoked potentials (MEP) facilitation in response to intraoperative ketamine administration
Change in supramaximal motor evoked potentials (MEP) in response to intraoperative ketamine administration
Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration
Secondary outcome measures
Ketamine Plasma Level
Trial Design
1Treatment groups
Experimental Treatment
Group I: KetamineExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,521 Previous Clinical Trials
15,242,194 Total Patients Enrolled
Marc Buren, MDPrincipal InvestigatorUniversity of California, San Francisco
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