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

NCT05591001 | Completed Phase 1

• 1 other identifier: N-83-2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Tethered Cord

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• fentanyl consumption in micrograms

  2 hours

• 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.

  2 hours

• 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

• First rescue of analgesia

  2 hours

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

  6 hours

Study Arms (2)

Ketamine-dexmedetomidine group

ACTIVE COMPARATOR

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.

Drug: ketamine and dexmeditomidine combination

propofol group

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

ketamine and dexmeditomidine combination DRUG

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

Ketamine-dexmedetomidine group

Propofol DRUG

propofol (100 ug /kg/min) infusion

propofol group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with ASA I and II presented to Abu elreesh hospital for untethered spinal cord surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amany Hassan Saleh

Giza, 02, Egypt

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Ketamine; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: . 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia ,surgical intensive care and pain management ,Cairo University

Model Details: forty six Children undergoing untethered spinal cord surgery will be randomly allocated into two equal groups using computerized generated random tables.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: October 30, 2022
• Primary Completion: March 20, 2023
• Study Completion: April 10, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

EG (1)