CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
low dexmedetomidine, low propofol +4 moredrug
Likely dose
low dexmedetomidine, low propofol 0.6 MCG/KGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00671931
NCT00671931Phase 1Completed

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

Children's Hospital Medical Center, Cincinnati·interventional·Posted May 5, 2008·Updated Aug 23, 2013

In Brief

A Phase 1 clinical trial evaluating low dexmedetomidine, low propofol, high dexmedetomidine, low propofol, and 2 other interventions for Scoliosis. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2008
Enrollment StartApr 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago

Interventions

low dexmedetomidine, low propofoldrug

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

high dexmedetomidine, low propofoldrug

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

Dexmedetomidinedrug

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

Dexmedetomidindrug

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

Dexmedetomidinedrug

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