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Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine

NCT ID: NCT00671931

Last Updated: 2013-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-01-31

Brief Summary

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Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.

Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

Detailed Description

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Conditions

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Scoliosis

Keywords

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dexmedetomidine neuromonitoring spine procedures safe dose 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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I

Dexmedetomidine low infusion, Propofol low infusion

Group Type ACTIVE_COMPARATOR

low dexmedetomidine, low propofol

Intervention Type DRUG

Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M

II

Dexmedetomidine high infusion, Propofol low infusion

Group Type ACTIVE_COMPARATOR

high dexmedetomidine, low propofol

Intervention Type DRUG

Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M

IV

Dexmedetomidine high infusion, Propofol high infusion

Group Type ACTIVE_COMPARATOR

Dexmedetomidin

Intervention Type DRUG

Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M

V

Dexmedetomidine intermediate infusion, Propofol intermediate infusion

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min

III

Dexmedetomidine low infusion, Propofol high infusion

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M

Interventions

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low dexmedetomidine, low propofol

Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M

Intervention Type DRUG

high dexmedetomidine, low propofol

Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M

Intervention Type DRUG

Dexmedetomidin

Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must be 10 to 25 years of age
* Diagnosis of idiopathic scoliosis is established
* Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate
* American society of Anesthesiology physical status one/two
* Patients scheduled for posterior spinal fusion only

Exclusion Criteria

* • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities

* Patients with allergy to, or contraindication for the drugs or techniques used in the study
* Morbid obesity (Body mass index higher than 40)
* History of malignant hyperthermia
* Patient with severe cardiopulmonary disease (pulmonary hypertension, cardiomyopathy, mechanical ventilation)
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Mahmoud, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinati Children Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Mahmoud M, Sadhasivam S, Salisbury S, Nick TG, Schnell B, Sestokas AK, Wiggins C, Samuels P, Kabalin T, McAuliffe J. Susceptibility of transcranial electric motor-evoked potentials to varying targeted blood levels of dexmedetomidine during spine surgery. Anesthesiology. 2010 Jun;112(6):1364-73. doi: 10.1097/ALN.0b013e3181d74f55.

Reference Type RESULT
PMID: 20460997 (View on PubMed)

Other Identifiers

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06-09-12

Identifier Type: -

Identifier Source: org_study_id