Effect of Ketamine on Intraoperative Motor Evoked Potentials
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (>18 years of age) undergoing posterior spinal fusions.
Disqualifiers
Sensitivity or allergy to ketamine.
Schizophrenia or other psychotic conditions
Uncontrolled hypertension with systolic blood pressure greater than 180 mmHg
Myocardial Infarction
Trial design
Design model
Single group
Treatments tested in this trial
Ketamine
DrugPatients will be administered ketamine at increasing doses followed by measurements of motor-evoked potentials.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: KetamineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 minutes2
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.
Time frame
30 minutes3
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.
Time frame
30 minutesSecondary outcomes
1
Ketamine Plasma Level
Ketamine Plasma levels will be measured at each of 3 ketamine doses.
Time frame
30 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov