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

NCT00671931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-08-23

Study results available
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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

Interventions

DRUG

low dexmedetomidine, low propofol

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

DRUG

high dexmedetomidine, low propofol

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

DRUG

Dexmedetomidine

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

DRUG

Dexmedetomidin

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

DRUG

Dexmedetomidine

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

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Mohamed Mahmoud, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671931 on ClinicalTrials.gov