The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

The Effects of Dexmedetomidine Dose on Motor Evoked Potentials During Spine Surgery: A Randomized, Single-blind Trial

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

Study Overview

• Status: Terminated
• Conditions: Spinal Fusion
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

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
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose dexmedetomidine; Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min	Drug: Dexmedetomidine; Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.; Other Names: Precedex
Active Comparator: Low dose dexmedetomidine; Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min	Drug: Dexmedetomidine; Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During a single surgery for the duration of the operation

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Ronald Emerson, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): October 17, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: motor evoked potentials
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2017-1304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes