Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

Dartmouth Health

Status and phase: Begins enrollment in 5 months; Phase 4

Conditions: Spinal Disease; Post Operative Pain; Anesthesia

Treatments: Drug: Normal saline; Drug: Lidocaine in Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06792474

STUDY02002708

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Lidocaine Infusion (Active)

Active Comparator group

Description:

Lidocaine infusion

Treatment:

Drug: Lidocaine in Saline

Normal Saline Infusion (Sham)

Sham Comparator group

Description:

Normal saline infusion

Treatment:

Drug: Normal saline