Spine FusionPhase 3NCT06140927
Effect of Ketamine on Intraoperative Motor Evoked Potentials
A Phase 3 study testing Ketamine in people with Spine Fusion and Spine Tumor, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spine Fusion, Spine Tumor, Spinal Stenosis
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years of age) undergoing posterior spinal fusions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Marc Buren, MD, 415-514-3781, marc.buren@ucsf.edu
About this study
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.
Read the detailed description
Spinal surgeries continue to increase in frequency and complexity. An important safety protocol is the use of intraoperative motor evoked potentials (MEP) to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury. Transcranial electric motor evoked potentials stimulate the motor cortex and produce a myogenic response. This modality can assess the function of all pathways including the motor cortex, the lateral corticospinal tracts, the function of the alpha motor neurons, and peripheral nerves.
Various anesthetic agents can impact the critical parameters of MEPs. Inhaled volatile anesthetics and nitrous oxide are highly suppressive in a dose-dependent manner decreasing the amplitude of the myogenic response and prolonging the latency. Propofol is also suppressive of MEPs, although high quality data can still be obtained at clinically relevant doses for anesthesia. For this reason, most anesthesiologists will use propofol as the backbone of any anesthetic that involves neurophysiologic monitoring.
Because spine surgeries are exceptionally painful, anesthesiologists will often incorporate adjuncts that can decrease pain and postoperative opioid usage. The effect of these adjuncts on intraoperative evoked potentials is incompletely described and important work remains to detail these effects.
Ketamine, a phencyclidine derivative that is an NMDA receptor antagonist, is a widely used adjunct anesthetic due to its analgesic and hypnotic properties during spine surgeries. Ketamine has shown significant opioid-sparing and analgesic benefits when used in patients undergoing spine surgery.
Intraoperative neuromonitoring (IONM), including motor evoked potentials (MEP), are increasingly used during spinal surgeries to help identify potentially reversible injury to neural structures.
The literature is full of conflicting and poor quality data regarding the effect of adding ketamine to an anesthetic and the effects on MEPs. Therefore, the investigators' goal is to help characterize the effects of this commonly used medication on a critical safety monitor for procedures involving the spinal cord.
The summation of excitation of spinal ventral horn neurons is thought to contribute to the myogenic response during transcranial motor evoked potentials. Because ketamine can inhibit N-methyl-D-aspartate receptor-mediated glutaminergic activity, it has the potential to inhibit this summation process and interfere with IONM. Despite this theoretical potential to interfere with IONM, ketamine is widely and successfully used during spinal surgeries. There are conflicting reports about the use of higher doses during surgery.
Prior studies have shown that moderate doses of ketamine have little to no effect on MEPs, and so for years the received wisdom was that ketamine is a benign agent, and is safe to using during spinal procedures utilizing IONM. However, following up on a case report, a group reported that even higher doses of ketamine may be able to dose dependently suppress MEPs. It is difficult to explain the differences between these reports, and it may be partially attributable to differences in neuromonitoring techniques/practices. These results are also interesting, because there is some suggestions in the community that it could be beneficial to run substantially higher doses of ketamine intraoperatively, using it not just as an opioid sparing adjunct, but more as a substantial contributor to the overall anesthestic state. The logic has been that ketamine, as opposed to propofol (the current foundation of an anesthetic compatible with IONM) has benign effects on MEPs and can reduce postoperative pain. However, if higher doses of ketamine can suppress MEPs, this change in anesthetic technique may not be warranted.
Protocol:
Main Visit: Patients will receive general anesthesia in the usual fashion for the indicated procedures. This anesthetic will be standardized between patients. The patients will also have the necessary equipment for neuromonitoring placed. This equipment is placed identically for patients who are or are not in our study, and the investigators will not add any additional monitors. 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. This baseline data is also standard practice and not a study-specific procedure. After the baseline data is collected patients will then be administered a bolus of ketamine 0.1mg/kg followed by an infusion of 3mcg/kg/min to maintain steady-state plasma levels. After 5 min to allow equilibration, a new set of baseline MEP data will be acquired. This process takes approximately 5 minutes. The investigators will also collect a blood specimen at this time to measure the ketamine plasma level. The investigators will then administer an additional bolus of 0.3 mg/kg of ketamine and increase the infusion to 15 mcg/kg/min to maintain steady-state plasma levels. The investigators will repeat the acquisition of baseline MEP data and a blood sample. Finally, the investigators will administer an additional bolus of 0.85 mg/kg of ketamine and increase the infusion to 50 mcg/kg/min to maintain steady-state plasma levels. The investigators will repeat the acquisition of baseline MEP data and a blood sample. Thereafter, the surgery will commence following usual anesthetic care at the discretion of the anesthesiologist. This dosing scheme is designed to mimic the steady-state plasma concentrations that would result from administering an infusion of 3mcg/kg/min, 15mcg/kg/min, and 50mcg/kg/min for prolonged periods of time. A commercial application for predicting plasma concentrations was used to calculate these doses.
General Demographic Data: Data including age, sex, race, and preoperative comorbid conditions will be collected. These data will be obtained by review of the patient's medical record.
Ketamine Plasma Levels: Blood samples will be collected by research personnel after each dose increase of ketamine and at the time the MEP data is obtained.
- Conditions
- Spine Fusion, Spine Tumor, Spinal Stenosis
- Being tested
- Ketamine
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Patients will be administered ketamine at increasing doses followed by measurements of motor-evoked potentials.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 minutes
Secondary outcomes (1)
Ketamine Plasma Level
Ketamine Plasma levels will be measured at each of 3 ketamine doses.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Buren, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140927
- Sponsor's protocol ID
- 23-39484
- Status last verified
- May 2025
- First submitted
- 24 Jul 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine on Intraoperative Motor Evoked Potentials
- ClinicalTrials.gov ID
- NCT06140927
- Acronym / sponsor ID
- 23-39484
- Conditions
- Spine Fusion, Spine Tumor, Spinal Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal surgeries continue to increase in frequency and complexity. An important safety protocol is the use of intraoperative motor evoked potentials (MEP) to monitor the integrity and function of the spinal cord and alert the surgeon of any potential injury. Transcranial electric motor evoked potentials stimulate the motor cortex and produce a myogenic response. This modality can assess the function of all pathways including the motor cortex, the lateral corticospinal tracts, the function of the alpha motor neurons, and peripheral nerves.
Various anesthetic agents can impact the critical parameters of MEPs. Inhaled volatile anesthetics and nitrous oxide are highly suppressive in a dose-dependent manner decreasing the amplitude of the myogenic response and prolonging the latency. Propofol is also suppressive of MEPs, although high quality data can still be obtained at clinically relevant doses for anesthesia. For this reason, most anesthesiologists will use propofol as the backbone of any anesthetic that involves neurophysiologic monitoring.
Because spine surgeries are exceptionally painful, anesthesiologists will often incorporate adjuncts that can decrease pain and postoperative opioid usage. The effect of these adjuncts on intraoperative evoked potentials is incompletely described and important work remains to detail these effects.
Ketamine, a phencyclidine derivative that is an NMDA receptor antagonist, is a widely used adjunct anesthetic due to its analgesic and hypnotic properties during spine surgeries. Ketamine has shown significant opioid-sparing and analgesic benefits when used in patients undergoing spine surgery.
Intraoperative neuromonitoring (IONM), including motor evoked potentials (MEP), are increasingly used during spinal surgeries to help identify potentially reversible injury to neural structures.
The literature is full of conflicting and poor quality data regarding the effect of adding ketamine to an anesthetic and the effects on MEPs. Therefore, the investigators' goal is to help characterize the effects of this commonly used medication on a critical safety monitor for procedures involving the spinal cord.
The summation of excitation of spinal ventral horn neurons is thought to contribute to the myogenic response during transcranial motor evoked potentials. Because ketamine can inhibit N-methyl-D-aspartate receptor-mediated glutaminergic activity, it has the potential to inhibit this summation process and interfere with IONM. Despite this theoretical potential to interfere with IONM, ketamine is widely and successfully used during spinal surgeries. There are conflicting reports about the use of higher doses during surgery.
Prior studies have shown that moderate doses of ketamine have little to no effect on MEPs, and so for years the received wisdom was that ketamine is a benign agent, and is safe to using during spinal procedures utilizing IONM. However, following up on a case report, a group reported that even higher doses of ketamine may be able to dose dependently suppress MEPs. It is difficult to explain the differences between these reports, and it may be partially attributable to differences in neuromonitoring techniques/practices. These results are also interesting, because there is some suggestions in the community that it could be beneficial to run substantially higher doses of ketamine intraoperatively, using it not just as an opioid sparing adjunct, but more as a substantial contributor to the overall anesthestic state. The logic has been that ketamine, as opposed to propofol (the current foundation of an anesthetic compatible with IONM) has benign effects on MEPs and can reduce postoperative pain. However, if higher doses of ketamine can suppress MEPs, this change in anesthetic technique may not be warranted.
Protocol:
Main Visit: Patients will receive general anesthesia in the usual fashion for the indicated procedures. This anesthetic will be standardized between patients. The patients will also have the necessary equipment for neuromonitoring placed. This equipment is placed identically for patients who are or are not in our study, and the investigators will not add any additional monitors. 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. This baseline data is also standard practice and not a study-specific procedure. After the baseline data is collected patients will then be administered a bolus of ketamine 0.1mg/kg followed by an infusion of 3mcg/kg/min to maintain steady-state plasma levels. After 5 min to allow equilibration, a new set of baseline MEP data will be acquired. This process takes approximately 5 minutes. The investigators will also collect a blood specimen at this time to measure the ketamine plasma level. The investigators will then administer an additional bolus of 0.3 mg/kg of ketamine and increase the infusion to 15 mcg/kg/min to maintain steady-state plasma levels. The investigators will repeat the acquisition of baseline MEP data and a blood sample. Finally, the investigators will administer an additional bolus of 0.85 mg/kg of ketamine and increase the infusion to 50 mcg/kg/min to maintain steady-state plasma levels. The investigators will repeat the acquisition of baseline MEP data and a blood sample. Thereafter, the surgery will commence following usual anesthetic care at the discretion of the anesthesiologist. This dosing scheme is designed to mimic the steady-state plasma concentrations that would result from administering an infusion of 3mcg/kg/min, 15mcg/kg/min, and 50mcg/kg/min for prolonged periods of time. A commercial application for predicting plasma concentrations was used to calculate these doses.
General Demographic Data: Data including age, sex, race, and preoperative comorbid conditions will be collected. These data will be obtained by review of the patient's medical record.
Ketamine Plasma Levels: Blood samples will be collected by research personnel after each dose increase of ketamine and at the time the MEP data is obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineAll 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>18 years of age) undergoing posterior spinal fusions.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetaminePatients will be administered ketamine at increasing doses followed by measurements of motor-evoked potentials. | Drug | Ketamine |
Primary outcome
Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration
Time frame: 30 minutes
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.
Change in supramaximal motor evoked potentials (MEP) in response to intraoperative ketamine administration
Time frame: 30 minutes
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.
Change in motor evoked potentials (MEP) facilitation in response to intraoperative ketamine administration
Time frame: 30 minutes
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.
1 secondary outcome
Ketamine Plasma Level
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No. The investigators will not plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Buren, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine in people with Spine Fusion and Spine Tumor, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Buren, MD (4154768369, marc.buren@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in threshold motor evoked potentials (MEP) in response to intraoperative ketamine administration (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.