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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

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
~1090

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,535 Total Patients Enrolled
Marc Buren, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently enrolling suitable candidates?

"As indicated on clinicaltrials.gov, this medical experiment is no longer seeking new applicants as the trial was initially posted on December 1st 2023 and last modified November 14th 2023. However, there are currently 111 other trials that require participants at this given time."

Answered by AI

To whom is this research opportunity available?

"Eligibility criteria for this clinical trial stipulates that applicants must have spinal stenosis and be aged between 18 and 100, with approximately 20 places available."

Answered by AI

Can adults aged 18 or above partake in this trial?

"This study is only open to people between 18 years old and 100. Meanwhile, there are additional clinical trials available for minors and seniors aged 65+."

Answered by AI

What has been the regulatory determination regarding Ketamine?

"The safety of Ketamine is evaluated to be a 3, since the Phase 4 classification indicates that it has been given approval."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Ketamine on Intraoperative Motor Evoked Potentials
2023. "Effect of Ketamine on Intraoperative Motor Evoked Potentials". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06140927.
~13 spots leftby Dec 2026
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