Clinical trial NCT06792474: Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spinal Disease
Anesthesia
Post Operative Pain
Keywords: Lidocaine
Intraoperative Neuromonitoring
Spine surgery
Post Operative Pain
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, double-blinded, randomized trial with randomization to lidocaine infusion or saline infusion for patients undergoing spine surgery with intraoperative neurophysiological monitoring
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective cervical or thoracolumbar spine surgery with intraoperative neurophysiological monitoring

Exclusion Criteria:

* Inability to provide informed consent in English
* Pregnancy (based on patient report or a positive test on the day of surgery)
* Contraindication to lidocaine
* Planned post-operative intubation
* Current incarceration

Primary outcomes:
measure: Motor Evoked Potentials (MEPs)
timeFrame: Duration of the surgical procedure, no more than 24 hours
Secondary outcomes:
measure: Somatosensory Evoked Potentials (SSEPs)
timeFrame: Duration of the surgical procedure, no more than 24 hours
measure: Mean Arterial Pressure (MAP)
timeFrame: Duration of the surgical procedure, no more than 24 hours
measure: Intraoperative propofol consumption
timeFrame: Duration of the surgical procedure, no more than 24 hours
measure: Visual Analog Scale (VAS) Pain Scores
timeFrame: Post-operative day 0 through 3
measure: Opiod consumption
timeFrame: Post-operative day 0 through 3
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
citation: Sloan TB, Mongan P, Lyda C, Koht A. Lidocaine infusion adjunct to total intravenous anesthesia reduces the total dose of propofol during intraoperative neurophysiological monitoring. J Clin Monit Comput. 2014 Apr;28(2):139-47. doi: 10.1007/s10877-013-9506-x. Epub 2013 Aug 31.
citation: Urban MK, Fields K, Donegan SW, Beathe JC, Pinter DW, Boachie-Adjei O, Emerson RG. A randomized crossover study of the effects of lidocaine on motor- and sensory-evoked potentials during spinal surgery. Spine J. 2017 Dec;17(12):1889-1896. doi: 10.1016/j.spinee.2017.06.024. Epub 2017 Jun 27.
citation: Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.
citation: Leliefeld PH, Wessels CM, Leenen LP, Koenderman L, Pillay J. The role of neutrophils in immune dysfunction during severe inflammation. Crit Care. 2016 Mar 23;20:73. doi: 10.1186/s13054-016-1250-4.
citation: Karnina R, Arif SK, Hatta M, Bukhari A. Molecular mechanisms of lidocaine. Ann Med Surg (Lond). 2021 Aug 17;69:102733. doi: 10.1016/j.amsu.2021.102733. eCollection 2021 Sep.
citation: Hollmann MW, Herroeder S, Kurz KS, Hoenemann CW, Struemper D, Hahnenkamp K, Durieux ME. Time-dependent inhibition of G protein-coupled receptor signaling by local anesthetics. Anesthesiology. 2004 Apr;100(4):852-60. doi: 10.1097/00000542-200404000-00015.
citation: Dewinter G, Moens P, Fieuws S, Vanaudenaerde B, Van de Velde M, Rex S. Systemic lidocaine fails to improve postoperative morphine consumption, postoperative recovery and quality of life in patients undergoing posterior spinal arthrodesis. A double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2017 Apr 1;118(4):576-585. doi: 10.1093/bja/aex038.
citation: Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.
citation: Schubert A, Licina MG, Glaze GM, Paranandi L. Systemic lidocaine and human somatosensory-evoked potentials during sufentanil-isoflurane anaesthesia. Can J Anaesth. 1992 Jul;39(6):569-75. doi: 10.1007/BF03008320.