Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:00 PM
Study NCT ID:
NCT06210061
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2023-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
A Comparative Study of Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
Status:
COMPLETED
Status Verified Date:
2025-12
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 objective of this study is to evaluate the effect of adding dexmedetomidine on evoked potentials in adult patients undergoing spinal surgery under intravenous anesthesia
Detailed Description:
A catastrophic complication of spinal surgery is nerve and spinal cord injury. The incidence of neurological defects after spinal surgery can be reduced from 3.7%-6.9% to less than 1% with proper electrophysiological monitoring.
Somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) are currently used as adjunct diagnostic methods in spinal surgery, such as scoliosis surgery and spinal stenosis decompression.
Total intravenous anesthesia (TIVA) with propofol and opioids is commonly used in SEPs and MEPs monitoring as it causes increase in latency in comparison to inhalational anesthetics that cause decrease in amplitude .
The amplitudes of MEPs and SEPs are reduced by halogenated volatile anesthetics, limiting their use in spinal surgery that requires electrophysiological monitoring. When volatile anesthetics did not exceed 0.3MAC, they had little effect on MEPs and SEPs . Martin et al. discovered that volatile agent-based anesthesia has application value during neurophysiological monitoring, such as faster awakening and rapid wake-up tests.
As well, volatile anesthetics can reduce the dosage of propofol. As a result, spinal surgery benefits from combined intravenous inhalation anesthesia. As an adjuvant, dexmedetomidine may be useful in reducing the need for propofol.
Dexmedetomidine is a potent and highly selective alpha-2 agonist. It has the effect of sedation, analgesia, sympatholytic, minimal respiratory depression and possible neuroprotection. Its addition to the anesthetic regimen is believed to have the potential of sparing other hypnotics requirement, especially propofol, thus facilitating MEP and SSEP monitoring while providing the beneficial effects it has.
Somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) are currently used as adjunct diagnostic methods in spinal surgery, such as scoliosis surgery and spinal stenosis decompression.
Total intravenous anesthesia (TIVA) with propofol and opioids is commonly used in SEPs and MEPs monitoring as it causes increase in latency in comparison to inhalational anesthetics that cause decrease in amplitude .
The amplitudes of MEPs and SEPs are reduced by halogenated volatile anesthetics, limiting their use in spinal surgery that requires electrophysiological monitoring. When volatile anesthetics did not exceed 0.3MAC, they had little effect on MEPs and SEPs . Martin et al. discovered that volatile agent-based anesthesia has application value during neurophysiological monitoring, such as faster awakening and rapid wake-up tests.
As well, volatile anesthetics can reduce the dosage of propofol. As a result, spinal surgery benefits from combined intravenous inhalation anesthesia. As an adjuvant, dexmedetomidine may be useful in reducing the need for propofol.
Dexmedetomidine is a potent and highly selective alpha-2 agonist. It has the effect of sedation, analgesia, sympatholytic, minimal respiratory depression and possible neuroprotection. Its addition to the anesthetic regimen is believed to have the potential of sparing other hypnotics requirement, especially propofol, thus facilitating MEP and SSEP monitoring while providing the beneficial effects it has.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: