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NCT Number: NCT05591001

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

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

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Key information

Conditions

Tethered Cord Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Amany Hassan Saleh

Giza, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine and dexmeditomidine combination

Drug

Dexmedetomidine( 0.4 -0.6 μg/.kg /.hr)) ketamine,( 1 -2m/.kg/.hr) infusion

Propofol

Drug

propofol (100 ug /kg/min) infusion

Primary outcomes

  1. the mean microvolts of 3 measurements of MEPs at 5 minutes interval at AH muscle before skin incision.

    Time frame: 2 hours

    the amplitude of motor evoked potentials measures

Secondary outcomes

  1. fentanyl consumption in micrograms

    Time frame: 2 hours

    total amount of fentanyl consumption intraoperatively

  2. Measurement of MEP at baseline once the patient will be prone , at surgical incision , and once exposure of the spine will be complete and during spinal manipulation and At the end of the surgery.

    Time frame: 2 hours

    Microvolt of MEP at baseline

  3. Measurements of blood pressure at base line T1, induction (T2) positioning( T3), skin incision (T4) , during spinal manipulation (T5)and by the end of the surgery (T6).

    Time frame: 2 hours

  4. First rescue of analgesia

    Time frame: 2 hours

  5. Side effects (sedation -hypotension ( MAP less than 25% from the baseline reading) - bradycardia - respiratory depression)

    Time frame: 6 hours

  6. Measurements of heart rate at baseline T1, induction T2, positioning T3,spinal manipulationT4,at the end of surgery T5

    Time frame: 2 hours

    Beats / minute?

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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