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

Phase 3

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

• Registration Number: NCT02592915
• Lead Sponsor: Queen Fabiola Children's University Hospital

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).

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Clonidine hydrochloride	Patients randomized in the Test Group will receive the clonidine hydrochloride
Control Group	Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level	Patients randomized in the Control Group will receive the Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period	perioperative period, up to 5H
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)

Trial Locations

Locations (1)

Queen Fabiola Children's University Hospital; 🇧🇪 Brussels, Belgium