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

Cairo University (CU)

Status and phase: Completed; Phase 1

Conditions: Tethered Cord

Treatments: Drug: ketamine and dexmeditomidine combination; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05591001

N-83-2022

Details and patient eligibility

About

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

Full description

A combination of ketamine and dexmeditomidine has several benefits in terms of hemodynamic stability, absence of respiratory depression, postoperative analgesia, and recovery. (11) ketamine could prevent the decrease of blood pressure and heart rate which had been observed with dexmedetomidine. In addition, dexmedetomidine could prevent the increase of blood pressure and heart rate, salivation, and physiological emergence reaction from ketamine. This combination was not previously used in this type of procedure except in a case report performed by Rozzana Penny who had used dexmedetomidine and ketamine infusion during scoliosis repair surgery with somatosensory and motor evoked potential monitoring in 15 years old female.(10) Evoked potentials are highly sensitive to fluctuations in physiological parameters such as peripheral and core body temperature, arterial blood pressure, hematocrit, etc. Keeping in view all the above factors we plan this study to compare the effect of the combinations of propofol and fentanyl versus the combination of ketamine and dexmedetomidine and fentanyl in producing a minimum effect on MEP amplitude and on hemodynamic stability during the surgery.

Enrollment: 46 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

Ketamine-dexmedetomidine group

Active Comparator group

Description:

Dexmedetomidine( 0.4 -0.6 μg/.kg /.h r)) ketamine,( 1-2m/.kg/.hr) infusion and giving bolus of fentanyl,( 1-2μg/.kg/ ) with keeping mean arterial blood pressure and heart rates changes within 25% of the baseline.

Treatment:

Drug: ketamine and dexmeditomidine combination

propofol group

Active Comparator group

Description:

propofol (100 ug/kg/min) -giving a bolus of fentanyl, (1-2μg/.kg/ ) with keeping mean arterial blood pressure and heart rate changes within 25% of the baseline.

Treatment:

Drug: Propofol