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| Name | Class |
|---|---|
| Brugmann University Hospital | OTHER |
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The purpose of this study is to assess the effect of IV clonidine administration on lower limb spinal motoneuron excitability during standardized total intravenous anesthesia (propofol and remifentanil).
According to the literature data, intraoperative administration of clonidine reduces the need for morphine per and postoperative and thus reduces the side effects associated related to their administration.
Nevertheless, on the basis of current knowledge, clonidine may disrupt some electrophysiological measures required for the intraoperative monitoring of surgeries with a high risk of neurological complications.
For such surgery, anaesthesiologists are led to inject clonidine after surgery, at a time when the electrophysiological measures are no longer needed, which limits the benefit in terms of intraoperative morphine savings.
Whith this study, investigators would like to investigate if an early administration of clonidine in patients aged 6 to 16 years undergoing ear surgery disturbs excitability of the spinal motor neuron.
The choice of the study population is justified by the fact that the ear surgery does not require electrophysiological monitoring and it is carried out under conditions similar to that of anesthesia of scoliosis corrective surgery for which electrophysiological measurements are essential for the prevention of neurological complications.
Observations will allow investigators to determine therefore whether early administration of clonidine is possible at high risk of neurological complications surgeries for which electrophysiological monitoring is essential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Patients randomized in the Test Group will receive the clonidine hydrochloride |
|
| Control Group | Placebo Comparator | Patients randomized in the Control Group will receive the Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine hydrochloride | Drug | Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration. | continuously during the surgery | |
| Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration | continuously during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period | perioperative period, up to 5H | |
| Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale | Every 30 minutes during the recovey period (up to 2H) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Françoise De Pooter, MD | Contact | 0032 3 477 39 96 | francoise.depooter@huderf.be | |
| Philippe Van der Linden, PhD | Contact | 0032 2 477 23 30 | philippe.vanderlinden@chu-brugmann.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Fabiola Children's University Hospital | Recruiting | Brussels | 1020 | Belgium |
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| Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level | Other |
|
| Sedative score using the University of Michigan Sedation Scale (UMSS) scale | Every 30 minutes during the recovery period (up to 2H) |
| Total dose of step 2 analgesic (tramadol) used for pain management | Total dose given during the recovery period (up to 2H) |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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