CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Isoflurane, Propofol, Dexmedetomidineother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01512147
NCT01512147N/ACompleted

Measuring the Effects of Dexmedetomidine on Somatosensory Evoked and Muscular Evoked Potential During Neurosurgery in Pediatric Patients

Oregon Health and Science University·interventional·Posted Jan 19, 2012·Updated Apr 5, 2018

In Brief

A clinical study evaluating Isoflurane, Propofol, Dexmedetomidine for Tethered Spinal Cord and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The investigators want to know if using the study drug dexmedetomidine will improve nerve wave readings during neurosurgery. These readings are done many times during surgery while the patient is asleep. The readings look at how nerves are working and let the operating team know if nerves are hurt during surgery. If the readings tell that nerves are not working correctly, the surgeons can help while changing the way of operating. The study drug will be used in addition to the general anesthesia that a patient is given. The nerve readings that the investigators get while using the study drug will be compared with nerve readings that the investigators get while not using the study drug. The study hypothesis is that dexmedetomidine does not change nerve readings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2012
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.5 years ago

Interventions

Isoflurane, Propofol, Dexmedetomidineother

We will include following general anesthesia techniques: Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250 mcg/kg/min, Isoflurane 0.6% expiratory With this general anesthesia technique we will do our first SSEP/MEP measurements after 30 minutes. After 30 minutes we will stop isoflurane and will wash out the inhalational anesthetic with high flow air/oxygen and provide: Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250mcg/kg/min. This technique will be held for 30 minutes. SSEP/ MEP measurements will be done after 30 minutes. After the measurements dexmedetomidine will be added with a loading dose of 0.5 mcg/kg over 10 minutes and continuous infusion of 0.5 mcg/kg/hr for 30 minutes. Fentanyl 1 -2 mcg/kg/hr, Propofol 100 - 250mcg/kg/min, Dexmedetomidine 0.5 mcg/kg/hr.