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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Brussels, Belgium, 1020
        • Recruiting
        • Queen Fabiola Children's University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francoise De Pooter, MD
        • Sub-Investigator:
          • Philippe Van der Linden, PhD
        • Sub-Investigator:
          • Paul Deltenre, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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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