Clinical trial · Interventional
Effect of Ketamine on Intraoperative Motor Evoked Potentials
NCT06140927CI-TRIAL-00089401recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Stenosis | — | UNRESOLVED | — |
| Spine Fusion | — | UNRESOLVED | — |
| Spine Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketamine
- description
- 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.
- interventionNames
- Drug: Ketamine
Primary outcomes (3)
- measure
- Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration
- timeFrame
- 30 minutes
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.