Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine and dexmeditomidine combination | Drug | Dexmedetomidine( 0.4 -0.6 μg/.kg /.hr)) ketamine,( 1 -2m/.kg/.hr) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| fentanyl consumption in micrograms | total amount of fentanyl consumption intraoperatively | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amany Hassan Saleh | Giza | 02 | Egypt |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
forty six Children undergoing untethered spinal cord surgery will be randomly allocated into two equal groups using computerized generated random tables.
Not provided
Not provided
. 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.
| Propofol | Drug | propofol (100 ug /kg/min) infusion |
|
Microvolt of MEP at baseline |
| 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 |
| Measurements of heart rate at baseline T1, induction T2, positioning T3,spinal manipulationT4,at the end of surgery T5 | Beats / minute? | 2 hours |
| D014947 | Wounds and Injuries |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |