Recruiting
Phase 3

Ketamine

Sponsor:

UCLA

Code:

NCT06140927

Conditions

Spine Fusion

Spine Tumor

Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketamine

Study Details

Brief 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.

Conditions

Spine Fusion

Spine Tumor

Spinal Stenosis

Study ID

NCT06140927

Start date

Dec 1, 2023

Status verified date

May, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (>18 years of age) undergoing posterior spinal fusions.

Exclusion Criteria:

  • Sensitivity or allergy to ketamine.
  • Schizophrenia or other psychotic conditions
  • Uncontrolled hypertension with systolic blood pressure greater than 180 mmHg
  • Myocardial Infarction
  • Large vascular aneurysms
  • Patients on ketamine as outpatient therapy.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Ketamine

Patients will be administered ketamine at increasing doses followed by measurements of motor-evoked potentials.

Primary outcome measure

  • Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration [ Time Frame: 30 minutes ]
  • Change in supramaximal motor evoked potentials (MEP) in response to intraoperative ketamine administration [ Time Frame: 30 minutes ]
  • Change in motor evoked potentials (MEP) facilitation in response to intraoperative ketamine administration [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Marc Buren, MD

4154768369marc.buren@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Marc Buren, MD

415-514-3781marc.buren@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

May 7, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-05-07.