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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03378973
Other study ID # 2017-1304
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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