Dartmouth-Hitchcock Medical Center
Lauren K. Buhl
The purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.
Spinal Disease
Anesthesia
Post Operative Pain
Lidocaine in Saline
Normal saline
PHASE4
The investigators will compare the stimulation threshold for motor evoked potentials (MEPs) for patients undergoing spine surgery with intraoperative neurophysiologic monitoring (IONM) who receive a lidocaine infusion vs. normal saline (NS) infusion. The endpoint for this objective will be the final stimulation threshold for MEPs at the end of the surgery. The stimulation threshold for MEPs is a commonly used metric to determine the effects of anesthetic agents on MEP signals. Secondary objectives will somatosensory evoked potentials (SSEPs) with an endpoint of amplitude and latency of SSEPs throughout the surgery. Other secondary outcomes will include, intraoperative mean arterial pressure (MAP), intraoperative propofol consumptions, and post-operative visual analog scale (VAS) and opioid consumption.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 44 participants |
| Masking : | TRIPLE |
| Masking Description : | The Research Pharmacy will compound lidocaine 2,000 mg (4 mg/mL) in 500 mL 0.9% sodium chloride or placebo (infusion bags will be aseptically prepared in a biological safety cabinet.) The lidocaine or placebo bags will be delivered and stored in the Same Day Procedure Omnicell machine prior to the day of procedure. The infusion bags will not be labeled as lidocaine or placebo in order not to unblind the blinded personnel administering the investigational product and will contain the calculated rate of infusion. |
| Primary Purpose : | TREATMENT |
| Official Title : | Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds; a Single-center, Double-blinded, Randomized Trial for Patients Undergoing Spin Surgery with Intraoperative Neurophysiologic Monitoring. |
| Actual Study Start Date : | 2025-08 |
| Estimated Primary Completion Date : | 2026-08 |
| Estimated Study Completion Date : | 2026-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
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Not yet recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766