Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
- Conditions
- Scoliosis
- Interventions
- Drug: low dexmedetomidine, low propofolDrug: high dexmedetomidine, low propofol
- Registration Number
- NCT00671931
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
-
• 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description I low dexmedetomidine, low propofol Dexmedetomidine low infusion, Propofol low infusion II high dexmedetomidine, low propofol Dexmedetomidine high infusion, Propofol low infusion IV Dexmedetomidin Dexmedetomidine high infusion, Propofol high infusion V Dexmedetomidine Dexmedetomidine intermediate infusion, Propofol intermediate infusion III Dexmedetomidine Dexmedetomidine low infusion, Propofol high infusion
- Primary Outcome Measures
Name Time Method Motor Evoked Potential Amplitude 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinati Children Medical Center
🇺🇸Cincinnati, Ohio, United States