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

NCT00671931 | Completed Phase 1 Results DMC

• 1 other identifier: 06-09-12
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Motor Evoked Potential Amplitude

  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.

  baseline, 30 minutes

Study Arms (5)

I

ACTIVE COMPARATOR

Dexmedetomidine low infusion, Propofol low infusion

Drug: low dexmedetomidine, low propofol

II

ACTIVE COMPARATOR

Dexmedetomidine high infusion, Propofol low infusion

Drug: high dexmedetomidine, low propofol

IV

ACTIVE COMPARATOR

Dexmedetomidine high infusion, Propofol high infusion

Drug: Dexmedetomidin

V

ACTIVE COMPARATOR

Dexmedetomidine intermediate infusion, Propofol intermediate infusion

Drug: Dexmedetomidine

III

ACTIVE COMPARATOR

Dexmedetomidine low infusion, Propofol high infusion

Drug: Dexmedetomidine

Interventions

low dexmedetomidine, low propofol DRUG

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

I

high dexmedetomidine, low propofol DRUG

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

II

Dexmedetomidine DRUG

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

III

Dexmedetomidin DRUG

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

IV

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinati Children Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 20460997 RESULT

MeSH Terms

Conditions

Scoliosis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mohamed Mahmoud, MD Principal Investigator
• Organization: Cincinnati Children's Hospital

mohamed.mahmoud@cchmc.org

513 636-7426

Study Officials

• Mohamed Mahmoud, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: April 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 23, 2013
• Results First Posted: August 23, 2013

Record last verified: 2013-08

Locations

US (1)