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

Queen Fabiola Children's University Hospital

Status and phase: Unknown; Phase 3

Conditions: Pain Management; Intraoperative Neurophysiological Monitoring

Treatments: Drug: Clonidine hydrochloride; Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level

Study type: Interventional

Funder types: Other

Identifiers

NCT02592915

P2014/PE2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Test Group

Experimental group

Description:

Patients randomized in the Test Group will receive the clonidine hydrochloride

Treatment:

Drug: Clonidine hydrochloride

Control Group

Placebo Comparator group

Description:

Patients randomized in the Control Group will receive the Placebo

Treatment:

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