Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity

Overview

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).

Full Title of Study: “Monocentric, Prospective Randomized Controlled Clinical Trial Assessing the Effect on the Lower Limb Spinal Motoneuron Excitability, the Efficacy in Term of Morphinic Sparing and Safety of of Early Clonidine Bolus Intravenous Administration During General Anesthesia in Children and Adolescent 6-18 Years Old Requesting Reconstructive Tympanic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2022

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

  • Drug: Clonidine hydrochloride
    • Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level
  • Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level

Arms, Groups and Cohorts

  • Experimental: Test Group
    • Patients randomized in the Test Group will receive the clonidine hydrochloride
  • Placebo Comparator: Control Group
    • Patients randomized in the Control Group will receive the Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.
    • Time Frame: continuously during the surgery
  • Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration
    • Time Frame: continuously during the surgery

Secondary Measures

  • Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period
    • Time Frame: perioperative period, up to 5H
  • Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale
    • Time Frame: Every 30 minutes during the recovey period (up to 2H)
  • Sedative score using the University of Michigan Sedation Scale (UMSS) scale
    • Time Frame: Every 30 minutes during the recovery period (up to 2H)
  • Total dose of step 2 analgesic (tramadol) used for pain management
    • Time Frame: Total dose given during the recovery period (up to 2H)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Queen Fabiola Children’s University Hospital
  • Collaborator
    • Brugmann University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Françoise De Pooter, MD, 0032 3 477 39 96, francoise.depooter@huderf.be

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