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

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ClinicalTrials.gov Identifier: NCT02592915
Recruitment Status : Recruiting
First Posted : October 30, 2015
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Brugmann University Hospital
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Intraoperative Neurophysiological Monitoring
  • Pain Management
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Test Group
    Patients randomized in the Test Group will receive the clonidine hydrochloride
    Intervention: Drug: Clonidine hydrochloride
  • Placebo Comparator: Control Group
    Patients randomized in the Control Group will receive the Placebo
    Intervention: Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Françoise De Pooter, MD 0032 3 477 39 96 francoise.depooter@huderf.be
Contact: Philippe Van der Linden, PhD 0032 2 477 23 30 philippe.vanderlinden@chu-brugmann.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02592915
Other Study ID Numbers  ICMJE P2014/PE2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Queen Fabiola Children's University Hospital
Study Sponsor  ICMJE Queen Fabiola Children's University Hospital
Collaborators  ICMJE Brugmann University Hospital
Investigators  ICMJE Not Provided
PRS Account Queen Fabiola Children's University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP