NCT00671931

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-05-05
• Last updated: 2013-08-23
• Results posted: 2013-08-23

Locations

1 site across 1 country: United States