Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

Phase 4

Not yet recruiting

• Conditions: Spinal Disease; Anesthesia; Post Operative Pain
• Interventions: Drug: Lidocaine in Saline; Drug: Normal saline

• Registration Number: NCT06792474
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-08
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Infusion (Active)	Lidocaine in Saline	Lidocaine infusion
Normal Saline Infusion (Sham)	Normal saline	Normal saline infusion

Primary Outcome Measures

Name	Time	Method
Motor Evoked Potentials (MEPs)	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 Outcome Measures

Name	Time	Method
Somatosensory Evoked Potentials (SSEPs)	Duration of the surgical procedure, no more than 24 hours	Endpoints of amplitude and latency throughout the surgery of SSEPs
Mean Arterial Pressure (MAP)	Duration of the surgical procedure, no more than 24 hours	Intraoperative incidence of MAP \<65 mmHg and MAP \< 55 mmHg
Intraoperative propofol consumption	Duration of the surgical procedure, no more than 24 hours	Rate of propofol consumption between the arms
Visual Analog Scale (VAS) Pain Scores	Post-operative day 0 through 3	Endpoint of VAS pain scores post operative days (POD) 0/1/3
Opiod consumption	Post-operative day 0 through 3	Opiod consumption converted to morphine equivalents through post operative day (POD) 3

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States