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Trial record 42 of 326 for:    clonidine

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 : August 8, 2018
Sponsor:
Collaborator:
Brugmann University Hospital
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

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).

Condition or disease Intervention/treatment Phase
Intraoperative Neurophysiological Monitoring Pain Management Drug: Clonidine hydrochloride Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Group
Patients randomized in the Test Group will receive the clonidine hydrochloride
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

Placebo Comparator: Control Group
Patients randomized in the Control Group will receive the Placebo
Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level



Primary Outcome Measures :
  1. Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration. [ Time Frame: continuously during the surgery ]
  2. Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration [ Time Frame: continuously during the surgery ]

Secondary Outcome Measures :
  1. Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period [ Time Frame: perioperative period, up to 5H ]
  2. 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) ]
  3. Sedative score using the University of Michigan Sedation Scale (UMSS) scale [ Time Frame: Every 30 minutes during the recovery period (up to 2H) ]
  4. Total dose of step 2 analgesic (tramadol) used for pain management [ Time Frame: Total dose given during the recovery period (up to 2H) ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592915


Contacts
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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

Locations
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Belgium
Queen Fabiola Children's University Hospital Recruiting
Brussels, Belgium, 1020
Contact: Bernard Wenderickx, Mr    0032 2 477 36 54    bernard.wenderickx@huderf.be   
Contact: Paul Mourlhou, Mr    0032 2 477 38 85    paul.mourlhou@huderf.be   
Principal Investigator: Francoise De Pooter, MD         
Sub-Investigator: Philippe Van der Linden, PhD         
Sub-Investigator: Paul Deltenre, PhD         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital
Brugmann University Hospital

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Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT02592915     History of Changes
Other Study ID Numbers: P2014/PE2
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Clonidine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action