Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06792474
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dartmouth-Hitchcock Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spinal Disease, Anesthesia, Post Operative Pain
Additional Details

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.#46; 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.

Arms & Interventions

Arms

Active Comparator: Lidocaine Infusion (Active)

Lidocaine infusion

Sham Comparator: Normal Saline Infusion (Sham)

Normal saline infusion

Interventions

Drug: - Lidocaine in Saline

Lidocaine infusion 1.5 mg/kg/hr

Drug: - Normal saline

Normal saline infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766

Site Contact

Lauren Buhl, MD, PhD

[email protected]

603-650-5000