The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03378973
• Other study ID #: 2017-1304
• Status: Terminated
• Phase: Phase 4
• Start date: November 28, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: April 2020
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Drug:
• Dexmedetomidine
Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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