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NCT Number: NCT06792474

Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

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

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Key information

Conditions

Spinal Disease Anesthesia Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location contact

Lauren Buhl, MD, PhD

CONTACT

[email protected]

603-650-5000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine in Saline

Drug

Lidocaine infusion 1.5 mg/kg/hr

Other names: Active

normal saline

Drug

Normal saline infusion

Other names: Placebo

Primary outcomes

  1. Motor Evoked Potentials (MEPs)

    Time frame: Duration of the surgical procedure, no more than 24 hours

    An endpoint of the final stimulation threshold for MEPs at the end of surgery.

Secondary outcomes

  1. Somatosensory Evoked Potentials (SSEPs)

    Time frame: Duration of the surgical procedure, no more than 24 hours

    Endpoints of amplitude and latency throughout the surgery of SSEPs

  2. Mean Arterial Pressure (MAP)

    Time frame: Duration of the surgical procedure, no more than 24 hours

    Intraoperative incidence of MAP <65 mmHg and MAP < 55 mmHg

  3. Intraoperative propofol consumption

    Time frame: Duration of the surgical procedure, no more than 24 hours

    Rate of propofol consumption between the arms

  4. Visual Analog Scale (VAS) Pain Scores

    Time frame: Post-operative day 0 through 3

    Endpoint of VAS pain scores post operative days (POD) 0/1/3

  5. Opiod consumption

    Time frame: Post-operative day 0 through 3

    Opiod consumption converted to morphine equivalents through post operative day (POD) 3

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren K Buhl, MD, PhD

CONTACT

[email protected]

603-650-5922

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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