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

Tethered Cord Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591001
• Other study ID #: N-83-2022
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 10, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tethered Cord

Intervention

Drug:
• ketamine and dexmeditomidine combination
Dexmedetomidine( 0.4 -0.6 µg/.kg /.hr)) ketamine,( 1 -2m/.kg/.hr) infusion
• Propofol
propofol (100 ug /kg/min) infusion

Locations

Country	Name	City	State
Egypt	Amany Hassan Saleh	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mean microvolts of 3 measurements of MEPs at 5 minutes interval at AH muscle before skin incision.	the amplitude of motor evoked potentials measures	2 hours
Secondary	fentanyl consumption in micrograms	total amount of fentanyl consumption intraoperatively	2 hours
Secondary	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.	Microvolt of MEP at baseline	2 hours
Secondary	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).		2 hours
Secondary	First rescue of analgesia		2 hours
Secondary	Side effects (sedation -hypotension ( MAP less than 25% from the baseline reading) - bradycardia - respiratory depression)		6 hours
Secondary	Measurements of heart rate at baseline T1, induction T2, positioning T3,spinal manipulationT4,at the end of surgery T5	Beats / minute?	2 hours