Dexmedetomidine on Intraoperative Somatosensory and Motor Evoked Potential Monitoring During Neurosurgery in Pediatric Patients
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 12 |
| Updated: | 4/17/2018 |
| Start Date: | December 2011 |
| End Date: | April 2018 |
Measuring the Effects of Dexmedetomidine on Somatosensory Evoked and Muscular Evoked Potential During Neurosurgery in Pediatric Patients
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.
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.
Somatosensory evoked potential (SSEP) and motor evoked potential (MEP) have become an
integral component in intraoperative care of patients and have resulted in a high degree of
sensitivity in predicting neurologic outcomes. According to Padberg, Nuwer and Ecker ,SSEP
and MEP monitoring allows surgical interventions to occur early and thus decreases the
incidence of postoperative neurologic deficits.
These measurements are done during surgery under general anesthesia and it is known that
anesthetic agents have a dose-dependent adverse effect on the ability to record evoked
potential responses. All anesthesia agents seem to interfere with the measurements especially
in higher doses.
In 1999, dexmedetomidine, a highly specific and selective alpha-2-adrenergic agonist with
sedative, anxiolytic and analgesic effects, got FDA approved for adult patients for sedation.
Since then, it has also been widely used off-label in various settings; it is described as a
successful adjunct for surgical procedures in adolescents and adult populations where SSEP/
MEP monitoring is beneficial. Several small and retrospective studies have shown that
dexmedetomidine does not appear to interfere with neurophysiological monitoring when used in
FDA approved doses.
In pediatric patients, dexmedetomidine is also used off-label and has been shown to be
beneficial. In fact, at Doernbecher Childen's Hospital, the use of dexmedetomidine has become
a standard in pediatric procedures involving SSEP and MEP measurements. To the best of our
knowledge, prospective studies in pediatric patients with SSEP monitoring while using
dexmedetomidine have not been completed.
If dexmedetomidine does not interfere the SSEP/MEP reading, it might be an advantageous
adjunct to use in these settings. Propofol has a small risk of a serious side effect called
propofol infusion syndrome. Propofol infusion syndrome is potentially life threatening, with
the development of a profound lactate acidosis. It is seen when large doses of propofol
(usually from a prolonged infusion) are given in the pediatric population.
integral component in intraoperative care of patients and have resulted in a high degree of
sensitivity in predicting neurologic outcomes. According to Padberg, Nuwer and Ecker ,SSEP
and MEP monitoring allows surgical interventions to occur early and thus decreases the
incidence of postoperative neurologic deficits.
These measurements are done during surgery under general anesthesia and it is known that
anesthetic agents have a dose-dependent adverse effect on the ability to record evoked
potential responses. All anesthesia agents seem to interfere with the measurements especially
in higher doses.
In 1999, dexmedetomidine, a highly specific and selective alpha-2-adrenergic agonist with
sedative, anxiolytic and analgesic effects, got FDA approved for adult patients for sedation.
Since then, it has also been widely used off-label in various settings; it is described as a
successful adjunct for surgical procedures in adolescents and adult populations where SSEP/
MEP monitoring is beneficial. Several small and retrospective studies have shown that
dexmedetomidine does not appear to interfere with neurophysiological monitoring when used in
FDA approved doses.
In pediatric patients, dexmedetomidine is also used off-label and has been shown to be
beneficial. In fact, at Doernbecher Childen's Hospital, the use of dexmedetomidine has become
a standard in pediatric procedures involving SSEP and MEP measurements. To the best of our
knowledge, prospective studies in pediatric patients with SSEP monitoring while using
dexmedetomidine have not been completed.
If dexmedetomidine does not interfere the SSEP/MEP reading, it might be an advantageous
adjunct to use in these settings. Propofol has a small risk of a serious side effect called
propofol infusion syndrome. Propofol infusion syndrome is potentially life threatening, with
the development of a profound lactate acidosis. It is seen when large doses of propofol
(usually from a prolonged infusion) are given in the pediatric population.
Inclusion Criteria:
- Pediatric patients between 2 and 12 years old
- Undergoing neurosurgery and
- Requiring SSEP/ MEP measurements
Exclusion Criteria:
- Patients younger than 2 and older than 12 years
- Patients with known bradyarrhythmias
- Patients with severe liver disease
- Conditions that may alter reading, e.g. neuromuscular diseases
We found this trial at
1
site
Portland, Oregon 97239
Principal Investigator: Heike Gries, MD, PhD
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