- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592915
Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity (EXCICLON)
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 Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Françoise De Pooter, MD
- Phone Number: 0032 3 477 39 96
- Email: francoise.depooter@huderf.be
Study Contact Backup
- Name: Philippe Van der Linden, PhD
- Phone Number: 0032 2 477 23 30
- Email: philippe.vanderlinden@chu-brugmann.be
Study Locations
-
-
-
Brussels, Belgium, 1020
- Recruiting
- Queen Fabiola Children's University Hospital
-
Contact:
- Bernard Wenderickx, Mr
- Phone Number: 0032 2 477 36 54
- Email: bernard.wenderickx@huderf.be
-
Contact:
- Paul Mourlhou, Mr
- Phone Number: 0032 2 477 38 85
- Email: paul.mourlhou@huderf.be
-
Principal Investigator:
- Francoise De Pooter, MD
-
Sub-Investigator:
- Philippe Van der Linden, PhD
-
Sub-Investigator:
- Paul Deltenre, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 6 to 18 years at time of hospital admission
- Planned hospital admission for tympanoplasty
- Informed Consent signed by both parents
Exclusion Criteria:
- Known hypersensitivity to clonidine or to any component of the Catapressan
- Patient treated with alpha2 agonists
- Surgical emergency
- Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
- Abnormal heart rhythms
- Neuromuscular disease
- Renal impairment
- Patient treated with methylphenidate
- Pregnant or breastfeeding woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Group
Patients randomized in the Test Group will receive the 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.
Time Frame: continuously during the surgery
|
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
|
continuously during the surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period
Time Frame: perioperative period, up to 5H
|
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)
|
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)
|
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)
|
Total dose given during the recovery period (up to 2H)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympatholytics
- Anesthetics
- Clonidine
Other Study ID Numbers
- P2014/PE2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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