Effect of a bolus of clonidine systemically administered on the excitability of the spinal motoneurons of the lower extremity

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 clonidin bolus intravenous administration during general anesthesia in children and adolescent 6-18 years old requesting reconstructive tympanic surgery. - EXCICLON Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002306-21-BE

Enrollment

Registered

2014-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri and post operative pain management MedDRA version: 17.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Catapressan Pharmaceutical Form: Solution for injection INN or Proposed INN: Catapressan Other descriptive name: CLONIDINE HYDROCHLORIDE Concentration unit: µg microgram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 6 to 18 years at time of hospital admission 2. Planned hospital admission for tympanosplasty 3. Informed Consent signed by both parents Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Must be completed;Secondary Objective: Must be completed;Primary end point(s): electrophysiological parameters of H-reflex and F-wave ;Timepoint(s) of evaluation of this end point: Continuously throughout the anesthesia	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Total dose of propofol and remifentanyl in mg/kg administered througout the perioperative period 2. Pain score using the CHEOPS/EVA scale 3. Sedative score using the UMSS scale 4. Total dose of step 2 analgesic (tramadol) used for pain management;Timepoint(s) of evaluation of this end point: 1. peri-operative period, started the asministration of clonidine to the end of the surgery 2. Pain scores will be assessed every 30min while the patient stay in the recovery room 3. Sedative scores will be assessed every 30min while the patient stay in the recovery room 4. Total dose of step 2 analgesic administered during the postanesthesia recovery period	—

Measure

Time frame

Secondary end point(s): 1. Total dose of propofol and remifentanyl in mg/kg administered througout the perioperative period 2. Pain score using the CHEOPS/EVA scale 3. Sedative score using the UMSS scale 4. Total dose of step 2 analgesic (tramadol) used for pain management;Timepoint(s) of evaluation of this end point: 1. peri-operative period, started the asministration of clonidine to the end of the surgery 2. Pain scores will be assessed every 30min while the patient stay in the recovery room 3. Sedative scores will be assessed every 30min while the patient stay in the recovery room 4. Total dose of step 2 analgesic administered during the postanesthesia recovery period

—

Countries

Belgium

Contacts

Public ContactClinical Research Unit

Hôpital Universitaire Des Enfants Reine Fabiola

bernard.wenderickx@huderf.be0032 2477 36 54

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026