Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine in Saline, Normal saline.
- Who it may be relevant to
- Registry conditions: Spinal Disease, Anesthesia, Post Operative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Drug Lidocaine in Saline
Lidocaine infusion 1.5 mg/kg/hr - Drug Normal saline
Normal saline infusion
Primary outcome measures
- Motor Evoked Potentials (MEPs) [Time frame: Duration of the surgical procedure, no more than 24 hours]
Secondary outcome measures (5)
- Somatosensory Evoked Potentials (SSEPs) [Time frame: Duration of the surgical procedure, no more than 24 hours]
- Mean Arterial Pressure (MAP) [Time frame: Duration of the surgical procedure, no more than 24 hours]
- Intraoperative propofol consumption [Time frame: Duration of the surgical procedure, no more than 24 hours]
- Visual Analog Scale (VAS) Pain Scores [Time frame: Post-operative day 0 through 3]
- Opiod consumption [Time frame: Post-operative day 0 through 3]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dartmouth Hitchcock Medical Center — Lebanon
Publications
- 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. PMID 23996498
- 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. PMID 28666848
- Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available. PMID 28114177
- 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. PMID 27005275
- 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. PMID 34457261
- 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. PMID 15087620
- 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. PMID 28403408
- 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. PMID 23681143
Identifiers
NCT: NCT06792474 · STUDY02002708