Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494832
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2007-06-28
Brief Title:
Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are
1 To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia during spine surgery and
2 To investigate the influence of Dexmedetomidine on the evoked potentials
1 To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia during spine surgery and
2 To investigate the influence of Dexmedetomidine on the evoked potentials
Detailed Description:
Use of evoked potentials can significantly improve neurologic outcome after major spine surgery Modalities of evoked potentials commonly used are Somato-Sensory Evoked Potentials SSEPs Motor Evoked Potentials MEPs and Visual Evoked Potentials VEPs
Dexmedetomidine DEX is an alpha-2 agonist and has been FDA approved as an adjunct sedative agent to general anesthesia It has been purported to reduce the amount of anesthetic required and potentiate the analgesic effect of opiates In addition DEX was shown to have minimal effect on SSEPs and VEPs in both rats and humans Any decrease in the dose of general anesthesia that improves the monitoring of evoked potentials supports DEX as an adjunct
It is known that all anesthetic agents can interfere with the recording of evoked potentials The choice of anesthetic however depends on the modality of neurophysiologic monitoring planned for the patient Total intravenous anesthesia TIVA and Sevoflurane a low dose inhalational anesthetic are the usual agents for spine surgery Both have a dose-related depressant effect on the quality of evoked potentials As a result it is common practice for the anesthesiologist to adjust the depth of anesthesia to improve signaling The use of either anesthetic must accompany continuous infusion of Propofol and an opioid Remifentanil or Fentanyl The anesthesiologist then decides whether DEX should be as an adjunct In our experience DEX did not impair evoked potentials In fact it improved the quality of signals in a few patients Yet there are no published data of such effects in medical literature
We hypothesize that Dexmedetomidine will not influence evoked potentials when used as an adjunct to general anesthesia Our study is prospective randomized double-blinded and will be carried out on a set of anesthetics We will first evaluate DEX as an adjunct in TIVA then as an adjunct to Sevoflurane The probable benefit of DEX may avoid the use of potent inhaled anesthetics which would improve VEPs monitoring Quality recording of evoked potentials can enhance our ability to detect iatrogenic injury to the spinal cord and vision
Dexmedetomidine DEX is an alpha-2 agonist and has been FDA approved as an adjunct sedative agent to general anesthesia It has been purported to reduce the amount of anesthetic required and potentiate the analgesic effect of opiates In addition DEX was shown to have minimal effect on SSEPs and VEPs in both rats and humans Any decrease in the dose of general anesthesia that improves the monitoring of evoked potentials supports DEX as an adjunct
It is known that all anesthetic agents can interfere with the recording of evoked potentials The choice of anesthetic however depends on the modality of neurophysiologic monitoring planned for the patient Total intravenous anesthesia TIVA and Sevoflurane a low dose inhalational anesthetic are the usual agents for spine surgery Both have a dose-related depressant effect on the quality of evoked potentials As a result it is common practice for the anesthesiologist to adjust the depth of anesthesia to improve signaling The use of either anesthetic must accompany continuous infusion of Propofol and an opioid Remifentanil or Fentanyl The anesthesiologist then decides whether DEX should be as an adjunct In our experience DEX did not impair evoked potentials In fact it improved the quality of signals in a few patients Yet there are no published data of such effects in medical literature
We hypothesize that Dexmedetomidine will not influence evoked potentials when used as an adjunct to general anesthesia Our study is prospective randomized double-blinded and will be carried out on a set of anesthetics We will first evaluate DEX as an adjunct in TIVA then as an adjunct to Sevoflurane The probable benefit of DEX may avoid the use of potent inhaled anesthetics which would improve VEPs monitoring Quality recording of evoked potentials can enhance our ability to detect iatrogenic injury to the spinal cord and vision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 064705 A01 | OTHER | University of Washington | None |