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OpenTrials
Completed

NCT Number: NCT00671931

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

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.

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Key information

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinati Children Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

low dexmedetomidine, low propofol

Drug

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

high dexmedetomidine, low propofol

Drug

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

Dexmedetomidine

Drug

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

Dexmedetomidin

Drug

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

Primary outcomes

  1. Motor Evoked Potential Amplitude

    Time frame: baseline, 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 5, 2008
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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