The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

Phase 4

Terminated

• Conditions: Spinal Fusion
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03378973
• Lead Sponsor: Hospital for Special Surgery, New York

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

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 Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Study Start: 2018-11-28
• Primary Completion: 2019-10-17
• Study Completion: 2019-10-17
• Results First Submitted: 2020-02-12
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Results First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose dexmedetomidine	Dexmedetomidine	Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min
High dose dexmedetomidine	Dexmedetomidine	Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min

Primary Outcome Measures

Name	Time	Method
Percent of Patients With Monitorable of Motor Evoked Potentials	During a single surgery for the duration of the operation	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.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States