Health TrialsbyHealthPanel

Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

ConditionsSpinal DiseaseAnesthesiaPost Operative Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients undergoing elective cervical or thoracolumbar spine surgery with intraoperative neurophysiological monitoring

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine in Saline

    Drug

    Lidocaine infusion 1.5 mg/kg/hr

  • Normal saline

    Drug

    Normal saline infusion

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Lidocaine Infusion (Active)Active comparator 1 intervention
Group B: Normal Saline Infusion (Sham)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Motor Evoked Potentials (MEPs)

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

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

Secondary outcomes

1

Somatosensory Evoked Potentials (SSEPs)

Endpoints of amplitude and latency throughout the surgery of SSEPs

Time frame
Duration of the surgical procedure, no more than 24 hours
2

Mean Arterial Pressure (MAP)

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

Time frame
Duration of the surgical procedure, no more than 24 hours
3

Intraoperative propofol consumption

Rate of propofol consumption between the arms

Time frame
Duration of the surgical procedure, no more than 24 hours
4

Visual Analog Scale (VAS) Pain Scores

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

Time frame
Post-operative day 0 through 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: