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

NCT ID: NCT02592915

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2022-12-31

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.

Conditions

Intraoperative Neurophysiological Monitoring; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Test Group

Patients randomized in the Test Group will receive the clonidine hydrochloride

Group Type: EXPERIMENTAL

Clonidine hydrochloride

Intervention Type: DRUG

Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level

Control Group

Patients randomized in the Control Group will receive the Placebo

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: OTHER

Interventions

Clonidine hydrochloride

Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: collaborator

Queen Fabiola Children's University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Queen Fabiola Children's University Hospital

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Françoise De Pooter, MD

Role: CONTACT

francoise.depooter@huderf.be

0032 3 477 39 96

Philippe Van der Linden, PhD

Role: CONTACT

philippe.vanderlinden@chu-brugmann.be

0032 2 477 23 30

Facility Contacts

Bernard Wenderickx, Mr

Role: primary

bernard.wenderickx@huderf.be

0032 2 477 36 54

Paul Mourlhou, Mr

Role: backup

paul.mourlhou@huderf.be

0032 2 477 38 85

Other Identifiers

P2014/PE2

Identifier Type: -

Identifier Source: org_study_id