Expired Study
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Cincinnati, Ohio 45229


Purpose:

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.


Criteria:

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)


Study is Available At:


Original ID:

06-09-12


NCT ID:

NCT00671931


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

10 Years


Maximum Age:

25 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Medical Center, Cincinnati


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mohamed Mahmoud, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati

Study Dates

Start Date:April 2007
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:August 22, 2013
First Received Date:April 30, 2008
First Results Date:June 24, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Motor Evoked Potential Amplitude
Time Frame:baseline, 30 minutes
Safety Issues:True
Description:The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.

Study Interventions

Intervention Type:Drug
Name:low dexmedetomidine, low propofol
Description:Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
Arm Name:I
Intervention Type:Drug
Name:high dexmedetomidine, low propofol
Description:Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
Arm Name:II
Intervention Type:Drug
Name:Dexmedetomidine
Description:Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
Arm Name:III
Intervention Type:Drug
Name:Dexmedetomidin
Description:Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
Arm Name:IV
Intervention Type:Drug
Name:Dexmedetomidine
Description:Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
Arm Name:V

Study Arms

Study Arm Type:Active Comparator
Arm Name:III
Description:Dexmedetomidine low infusion, Propofol high infusion
Study Arm Type:Active Comparator
Arm Name:V
Description:Dexmedetomidine intermediate infusion, Propofol intermediate infusion
Study Arm Type:Active Comparator
Arm Name:IV
Description:Dexmedetomidine high infusion, Propofol high infusion
Study Arm Type:Active Comparator
Arm Name:II
Description:Dexmedetomidine high infusion, Propofol low infusion
Study Arm Type:Active Comparator
Arm Name:I
Description:Dexmedetomidine low infusion, Propofol low infusion

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Medical Center, Cincinnati

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:20460997

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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