Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity

Pain Management Clinical Trial

— EXCICLON  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592915
• Other study ID #: P2014/PE2
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: December 2022

Study information

• Verified date: January 2020
• Source: Queen Fabiola Children's University Hospital
• Contact: Françoise De Pooter, MD
• Phone: 0032 3 477 39 96
• Email: francoise.depooter[@]huderf.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Neurophysiological Monitoring
• Pain Management

Intervention

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

Other:
• Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level

Locations

Country	Name	City	State
Belgium	Queen Fabiola Children's University Hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital	Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.		continuously during the surgery
Primary	Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration		continuously during the surgery
Secondary	Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period		perioperative period, up to 5H
Secondary	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)
Secondary	Sedative score using the University of Michigan Sedation Scale (UMSS) scale		Every 30 minutes during the recovery period (up to 2H)
Secondary	Total dose of step 2 analgesic (tramadol) used for pain management		Total dose given during the recovery period (up to 2H)