Intraoperative Neurophysiological MonitoringPhase 3EXCICLONNCT02592915
Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity
A Phase 3 study testing Clonidine hydrochloride and Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level in people with Intraoperative Neurophysiological Monitoring and Pain Management, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Intraoperative Neurophysiological Monitoring, Pain Management
- What is being tested?
- Clonidine hydrochloride and Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 6 to 18 years at time of hospital admission
- Planned hospital admission for tympanoplasty
- Informed Consent signed by both parents
Who cannot join
- Known hypersensitivity to clonidine or to any component of the Catapressan
- Patient treated with alpha2 agonists
- Surgical emergency
- Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
- Abnormal heart rhythms
- Neuromuscular disease
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- Renal impairment
- Patient treated with methylphenidate
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Queen Fabiola Children's University Hospital
Brussels, 1020
Bernard Wenderickx, Mr, 0032 2 477 36 54, bernard.wenderickx@huderf.be
Paul Mourlhou, Mr, 0032 2 477 38 85, paul.mourlhou@huderf.be
About this study
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
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).
Read the 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.
- Being tested
- Clonidine hydrochloride, Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine hydrochlorideDrug
Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level
Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic levelOther
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Patients randomized in the Test Group will receive the clonidine hydrochloride Receives: Drug: Clonidine hydrochloride |
| Control Group | Placebo comparator | Patients randomized in the Control Group will receive the Placebo Receives: Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.
Measured: continuously during the surgery
Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration
Measured: continuously during the surgery
Secondary outcomes (4)
Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period
Measured: perioperative period, up to 5H
Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale
Measured: Every 30 minutes during the recovey period (up to 2H)
Sedative score using the University of Michigan Sedation Scale (UMSS) scale
Measured: Every 30 minutes during the recovery period (up to 2H)
Total dose of step 2 analgesic (tramadol) used for pain management
Measured: Total dose given during the recovery period (up to 2H)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Neurophysiological MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brugmann University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592915
- Sponsor's protocol ID
- P2014/PE2
- Acronym
- EXCICLON
- Status last verified
- Jan 2020
- First submitted
- 20 Oct 2015
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02592915
- Acronym / sponsor ID
- EXCICLON / P2014/PE2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Collaborators
- Brugmann University Hospital
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Clonidine hydrochloridePatients randomized in the Test Group will receive the clonidine hydrochloride |
| Control Group | Placebo comparator | Other: Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic levelPatients randomized in the Control Group will receive the Placebo |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 6 to 18 years at time of hospital admission
- Planned hospital admission for tympanoplasty
- Informed Consent signed by both parents
Key exclusion criteria (9 listed)
- Known hypersensitivity to clonidine or to any component of the Catapressan
- Patient treated with alpha2 agonists
- Surgical emergency
- Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
- Abnormal heart rhythms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine hydrochlorideSingle bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level | Drug | Test Group |
| Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level | Other | Control Group |
Primary outcome
Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration.
Time frame: continuously during the surgery
Evaluation of the spinal motoneuron excitability through the measurement of H reflex before and after clonidine administration
Time frame: continuously during the surgery
4 secondary outcomes
Total dose of propofol and remifentanyl in mg/kg administered throughout the perioperative period
Time frame: perioperative period, up to 5H
Pain score using the Children Hospital of Eastern Ontario Pain Scale (CHEOPS) or EVA scale
Time frame: Every 30 minutes during the recovey period (up to 2H)
Sedative score using the University of Michigan Sedation Scale (UMSS) scale
Time frame: Every 30 minutes during the recovery period (up to 2H)
Total dose of step 2 analgesic (tramadol) used for pain management
Time frame: Total dose given during the recovery period (up to 2H)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clonidine hydrochloride and Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level in people with Intraoperative Neurophysiological Monitoring and Pain Management, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Françoise De Pooter, MD (0032 3 477 39 96, francoise.depooter@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the spinal motoneuron excitability through the measurement of the F wave before and after clonidine administration. (time frame: continuously during the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.