Intraoperative Neurophysiological Monitoring, Pain Management
Conditions
Brief summary
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).
Detailed description
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.
Interventions
Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level
OTHERSingle bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level
Sponsors
Brugmann University Hospital
Queen Fabiola Children's University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 6 to 18 years at time of hospital admission 2. Planned hospital admission for tympanoplasty 3. Informed Consent signed by both parents
Exclusion criteria
1. Known hypersensitivity to clonidine or to any component of the Catapressan 2. Patient treated with alpha2 agonists 3. Surgical emergency 4. Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant) 5. Abnormal heart rhythms 6. Neuromuscular disease 7. Renal impairment 8. Patient treated with methylphenidate 9. Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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) |
| 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) |
Countries
Belgium
Contacts
Primary ContactFrançoise De Pooter, MD
Backup ContactPhilippe Van der Linden, PhD
Outcome results
None listed