Actively Recruiting

Phase 3
Age: 18Years - 100Years
All Genders
ID06140927

Effect of Ketamine on Intraoperative Motor Evoked Potentials During Adult Thoracolumbar Spinal Fusion Surgery

Led by University of California, San Francisco · Updated on 2025-05-07

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how ketamine affects intraoperative motor evoked potentials (MEPs) in adult patients undergoing thoracolumbar spinal fusion surgeries. Spinal surgeries often use MEP monitoring to ensure the spinal cord's function is preserved during the procedure. Since ketamine is commonly used as an anesthetic adjunct to reduce pain and opioid use during these surgeries, the study evaluates its impact on this important safety monitoring technique. Participants will receive a standardized general anesthetic along with increasing doses of ketamine administered in three steps: a 0.1 mg/kg bolus followed by infusion at 3 mcg/kg/min, then a 0.3 mg/kg bolus with infusion at 15 mcg/kg/min, and finally a 0.85 mg/kg bolus with infusion at 50 mcg/kg/min. Motor evoked potentials will be recorded multiple times after each dosing step, and blood samples will be taken to measure ketamine plasma levels. After these assessments, the surgery will continue per usual care. During the procedure, participants will have neuromonitoring equipment placed as part of standard care to collect baseline and post-ketamine MEP data. Researchers will collect demographic and medical information from patient records. The primary measures include changes in threshold and supramaximal MEPs and MEP facilitation within 30 minutes of ketamine administration. The study will monitor safety and ketamine blood levels, with total participation lasting through the surgical procedure.

CONDITIONS

Brief Title

Effect of Ketamine on Intraoperative Motor Evoked Potentials

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (>18 years of age) undergoing posterior spinal fusions.
Not Eligible

You will not qualify if you...

  • Sensitivity or allergy to ketamine.
  • Schizophrenia or other psychotic conditions.
  • Uncontrolled hypertension with systolic blood pressure greater than 180 mmHg.
  • History of myocardial infarction.
  • Presence of large vascular aneurysms.
  • Patients currently on ketamine as outpatient therapy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Approximately 1 day

Participants undergo thoracolumbar spinal fusion surgery with standardized general anesthesia and intraoperative neuromonitoring including motor evoked potentials (MEP).

1 visit (in-person) during surgery

Treatment

Duration - Approximately 30 minutes during surgery

Participants receive increasing doses of ketamine administered intraoperatively with collection of motor evoked potential data and blood samples to measure ketamine plasma levels.

Continuous monitoring and data collection during surgery

Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

M

Marc Buren, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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