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

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).

Study Overview

• Status: Unknown
• Conditions: Pain Management; Intraoperative Neurophysiological Monitoring
• Intervention / Treatment: Drug: Clonidine hydrochloride; Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • 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: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

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.	continuously during the surgery
Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration	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	perioperative period, up to 5H
Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale	Every 30 minutes during the recovey period (up to 2H)
Sedative score using the University of Michigan Sedation Scale (UMSS) scale	Every 30 minutes during the recovery period (up to 2H)
Total dose of step 2 analgesic (tramadol) used for pain management	Total dose given during the recovery period (up to 2H)

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital
• Collaborators: Brugmann University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

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