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
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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
- 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 ]
- 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) ]
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
|Contact: Françoise De Pooter, MD||0032 3 477 39 firstname.lastname@example.org|
|Contact: Philippe Van der Linden, PhD||0032 2 477 23 email@example.com|
|Queen Fabiola Children's University Hospital||Recruiting|
|Brussels, Belgium, 1020|
|Contact: Bernard Wenderickx, Mr 0032 2 477 36 54 firstname.lastname@example.org|
|Contact: Paul Mourlhou, Mr 0032 2 477 38 85 email@example.com|
|Principal Investigator: Francoise De Pooter, MD|
|Sub-Investigator: Philippe Van der Linden, PhD|
|Sub-Investigator: Paul Deltenre, PhD|