The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2019-10-17

Brief Summary

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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

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Detailed Description

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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

Conditions

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Spinal Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.

Study Groups

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High dose dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Low dose dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No