Clinical trial

A Comparative Study of the Effect of Propofol Infusion Versus the Combination of Ketamine and Dexmedetomidine Infusion on the Amplitude of Motor Evoked Potential in Pediatrics Undergoing Tethered Spinal Cord Surgeries a Randomized, Double-blinded Controlled Study

Name
N-83-2022
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
Trial arms
Trial start
2022-10-30
Estimated PCD
2023-03-20
Trial end
2023-04-10
Status
Completed
Phase
Early phase I
Treatment
ketamine and dexmeditomidine combination
Dexmedetomidine( 0.4 -0.6 μg/.kg /.hr)) ketamine,( 1 -2m/.kg/.hr) infusion
Arms:
Ketamine-dexmedetomidine group
Propofol
propofol (100 ug /kg/min) infusion
Arms:
propofol group
Size
46
Primary endpoint
the mean microvolts of 3 measurements of MEPs at 5 minutes interval at AH muscle before skin incision.
2 hours
Eligibility criteria
Inclusion Criteria: * children with ASA I and II presented to Abu elreesh hospital for untethered spinal cord surgery. Exclusion Criteria: * Children with neuromuscular diseases or congenital scoliosis. * Children with growing rod distraction surgery. * Children with American Society of Anaesthesiologists (ASA) physical status III, IV * Children with preoperative use of antidepressant or anticonvulsant medications. * Children with a known history of drug allergies.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'forty six Children undergoing untethered spinal cord surgery will be randomly allocated into two equal groups using computerized generated random tables.', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '. The details of the series will be unknown to the investigators and the group assignment will be kept in a set of sealed envelopes, each bearing only the case number on the outside. a person who will prepare the drugs and data collector is not one of the trial investigators.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2024-02-07

1 organization

2 products

1 indication

Organization
Cairo University
Indication
Tethered Cord
Product
Propofol