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

• Sponsor: Queen Fabiola Children's University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02592915
• Collaborator: Brugmann University Hospital (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 86
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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).

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

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• 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: Oct 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration. [continuously during the surgery]

2. Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration [continuously during the surgery]

Secondary Outcome Measures

1. Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period [perioperative period, up to 5H]

2. 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)]

3. Sedative score using the University of Michigan Sedation Scale (UMSS) scale [Every 30 minutes during the recovery period (up to 2H)]

4. Total dose of step 2 analgesic (tramadol) used for pain management [Total dose given during the recovery period (up to 2H)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Fabiola Children's University Hospital	Brussels		Belgium	1020

Sponsors and Collaborators

• Queen Fabiola Children's University Hospital
• Brugmann University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Queen Fabiola Children's University Hospital
• ClinicalTrials.gov Identifier: NCT02592915
• Other Study ID Numbers: P2014/PE2
• First Posted: Oct 30, 2015
• Last Update Posted: Jan 29, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Clonidine; Anesthetics

Study Results

No Results Posted as of Jan 29, 2020