The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

Phase 4TerminatedNCT03378973

Hospital for Special Surgery, New York7 enrolled

Overview

This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery

This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Spinal Fusion

Interventions

DexmedetomidineDRUG

Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring Exclusion Criteria: * Allergy to dexmedetomidine, propofol * Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain * Hepatic disease

Locations (1)

Hospital for Special Surgery

New York, New York, United States

Outcomes

Primary Outcomes

Percent of Patients With Monitorable of Motor Evoked Potentials

Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.

Time frame: During a single surgery for the duration of the operation

Data from ClinicalTrials.gov

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