The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

NCT03378973 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2017-1304
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Fusion

Keywords

motor evoked potentials

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

High dose dexmedetomidine

EXPERIMENTAL

Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min

Drug: Dexmedetomidine

Low dose dexmedetomidine

ACTIVE COMPARATOR

Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

High dose dexmedetomidine; Low dose dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ronald Emerson, MD
• Organization: Hospital for Special Surgery

emersonr@hss.edu

2127742742

Study Officials

• Ronald Emerson, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 20, 2017
• Study Start: November 28, 2018
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: April 28, 2020
• Results First Posted: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)