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NCT05591001

Effects of Anesthetic Infusion on the Amplitude of Motor Evoked Potential in Pediatrics Undergoing Tethered Spinal Cord Surgeries

Completed Phase 1 Last updated 7 February 2024
What this trial tests

Phase 1 trial testing ketamine and dexmeditomidine combination in Tethered Cord in 46 participants. Completed in 10 April 2023.

Timeline
30 October 2022
Primary endpoint
20 March 2023
10 April 2023

Quick facts

Lead sponsorCairo University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposehealth services research
Enrollment46
Start date30 October 2022
Primary completion20 March 2023
Estimated completion10 April 2023
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Cairo University

Who can join

Adults 3 to 8, any sex, with Tethered Cord. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The tethered spinal cord is a common pathology in pediatric neurosurgery. Intraoperative neurophysiologic monitoring (IOM) has gained popularity over the past two decades as a clinical discipline that uses neurophysiologic techniques to detect and prevent iatrogenic neurologic injuries. IOM techniques are extensively used in adult neurosurgery and, in their principles, can be applied to the pediatric population. Inhalational agents cause a dose-dependent reduction in MEPs and are arguably considered incompatible with effective neurophysiological monitoring(5) For this reason, total intravenous anesthesia (TIVA), using IV anesthetics (propofol or ketamine) and opioids (fentanyl or remifentanil), is commonly used in spinal surgeries under MEPs monitoring

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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