Effect of Ketamine on Intraoperative Motor Evoked Potentials

NCT06140927 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 23-39484
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration

  MEP helps to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury during the spine surgery. MEP amplitude will be measured at each of 3 ketamine doses and compared to baseline. The measurements will be at each dose change of ketamine approximately 10, 20 and 30 minutes after the start of the ketamine infusions.

  30 minutes

• Change in supramaximal motor evoked potentials (MEP) in response to intraoperative ketamine administration

  MEP helps to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury during the spine surgery. MEP amplitude will be measured at each of 3 ketamine doses and compared to baseline. The measurements will be at each dose change of ketamine approximately 10, 20 and 30 minutes after the start of the ketamine infusions.

  30 minutes

• Change in motor evoked potentials (MEP) facilitation in response to intraoperative ketamine administration

  MEP helps to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury during the spine surgery. MEP amplitude will be measured at each of 3 ketamine doses and compared to baseline. The measurements will be at each dose change of ketamine approximately 10, 20 and 30 minutes after the start of the ketamine infusions.

  30 minutes

Secondary Outcomes (1)

• Ketamine Plasma Level

  30 minutes

Study Arms (1)

Ketamine

EXPERIMENTAL

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.

Drug: Ketamine

Interventions

Ketamine DRUG

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

Ketamine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marc Buren, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Buren, MD

CONTACT

4154768369; marc.buren@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will serve as their own control and baseline measurements will be made before the administration of study drug. After baseline measurements, increasing doses of the study drug will be administered and effects measured.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: November 21, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)