Procedural Sedation and AnalgesiaDINAMONCT06867289
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
A study testing EEG in people with Procedural Sedation and Analgesia and Pediatric ALL, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This is a prospective, monocentric diagnostic study aiming to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Procedural Sedation and Analgesia, Pediatric ALL
- What is being tested?
- EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2025to 8 Apr 2027
- Phase
- Interventional
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Indication of DEX sedation for brain NMRI at the CHR de Metz-Thionville
- in a patient aged between 12 months and 5 years or
- for a patient aged between 5 and 18 whose cooperation during the examination appears compromised (previous failure, autism spectrum disorders, etc.).
- Membership of a social security scheme
- Free and informed consent obtained from the patient's legal guardian(s).
Who cannot join
- Weight < 10 kg
- Patients with contraindications to the use of DEX
- Hypersensitivity to the active ingredient or to any of the excipients listed in the section on "Hypersensitivity".
- Advanced heart block (level 2 or 3), unless pacemaker implanted
- Uncontrolled hypotension
- Acute cerebrovascular pathologies
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- Patients with nasal obstruction
- Parental refusal of DEX administration
- Minors under guardianship
- Minors under judicial sanction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville Hopital Femme-Mère Enfant
Metz, 57085
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Anne-Charlotte CULLIER, MD
About this study
This is a prospective, monocentric diagnostic study aiming to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore benefit from a higher dosage of DEX (4 μg/kg).
Read the detailed description
For some children, brain MRI is a particularly important examination for etiological assessment or for monitoring the progress of neurological diseases. It can sometimes be complicated to perform, due to the age and/or pathology of the child concerned. Impossibility, postponement or the need for a general anaesthetic are constraints that should be avoided as far as possible. Procedural sedation with dexmedetomidine (DEX) can be administered intra-nasally. This technique offers good results and safety of use. Nevertheless, the failure rate is 20% to 30%, and may depend on the dosage of DEX used (indicated doses vary from 2 to 4 μg/kg). This study aims to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore benefit from a higher dosage of DEX (4 μg/kg).
- Conditions
- Procedural Sedation and Analgesia, Pediatric ALL
- Being tested
- EEG
- Keywords
- MRI, dexmedetomidine, EEG
- Medical subject headings
- Agnosia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
EEG monitoring will be performed in addition to the usual practice, before DEX administration and for 20 minutes before NMRI, to enable calculation of the PSI sedation score (at 0, 10, 20 minutes). Sedation will also be assessed by the PSSS clinical score at 0, 10, 20 minutes after DEX administration, as well as at 150 minutes after DEX.
| Study group | Role | What they receive |
|---|---|---|
| EEG Monitoring and PSSS clinical score | Experimental | All participants receive an EEG monitoring. Receives: Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of complete NMRI success
To describe the predictive value (ROC curve) of the PSI score assessed 20 minutes after administration of 2 μg/kg of DEX intranasally, for complete success in performing brain NMRI in children under 5 years of age, or over 5 years of age with risk of failure.
Successful NMRI is defined as:
- Complete if all prescribed sequences can be interpreted without reservation,
- Partial if some of the sequences cannot be interpreted or are subject to reservations by the radiologist,
- Absent if the examination is cancelled or if all sequences are uninterpretable or subject to reservations.
PSI score: evaluated on EEG, the score varies from 0 to 100.
Measured: 20 minutes after DEX administration
Secondary outcomes (9)
Complete or partial success in performing brain NMRI in children under 5 years of age, or over 5 years of age with risk of failure.
Area under the ROC curve for prediction of complete or partial success of NMRI according to PSI score.
Successful NMRI is defined as:
- Complete if all prescribed sequences can be interpreted without reservation,
- Partial if some of the sequences cannot be interpreted or are subject to reservations by the radiologist,
- Absent if the examination is cancelled or if all sequences are uninterpretable or subject to reservations.
Measured: 20 minutes after DEX administration
Predictive value (ROC curve) of the PSI score for successful completion of brain MRI in children under 5 years of age, or over 5 years of age with risk of failure.
Area under the ROC curve for prediction of complete success of NMRI according to PSI score by patient age under or over 5 years old
Successful NMRI is defined as:
- Complete if all prescribed sequences can be interpreted without reservation,
- Partial if some of the sequences cannot be interpreted or are subject to reservations by the radiologist,
- Absent if the examination is cancelled or if all sequences are uninterpretable or subject to reservations.
PSI score: evaluated on EEG, the score varies from 0 to 100.
Measured: 20 min after DEX administration
Predictive value (ROC curve) of the PSSS score for successful completion of brain MRI in children under 5 years of age, or over 5 years of age with risk of failure.
Area under the ROC curve for prediction of complete or partial success of NMRI according to PSSS score at 20 minutes
Successful NMRI is defined as:
- Complete if all prescribed sequences can be interpreted without reservation,
- Partial if some of the sequences cannot be interpreted or are subject to reservations by the radiologist,
- Absent if the examination is cancelled or if all sequences are uninterpretable or subject to reservations.
PSSS score: ranges from 0 (deepest sedation) to 5 (shallowest sedation) depending on the observation of clinical signs in children
Measured: 20 min after DEX administration
Correlation between PSI and PSSS scores
Describe the correlation between PSI score and PSSS score PSI scores at 0, 10, 20 and 150 minutes after DEX administration and PSSS scores at 0, 10, 20 and 150 minutes after DEX administration
Measured: at 0, 10, 20 and 150 minutes after DEX administration
Complications (Quality of recovery)
PSSS score: ranges from 0 (deepest sedation) to 5 (shallowest sedation) depending on the observation of clinical signs in children
Measured: at 150 minutes after DEX administration
Complications (Blood Pressure)
mmHg
Measured: at 0, 10, 20 and 150 minutes after DEX administration
Complications (Heart Rate)
bpm
Measured: at 0, 10, 20 and 150 minutes after DEX administration
Complications (Oxygen Saturation)
SaO2 (%)
Measured: at 0, 10, 20 and 150 minutes after DEX administration
Complications (allergic reactions)
number and types
Measured: at 0, 10, 20 and 150 minutes after DEX administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start8 Apr 2025
- Primary completion8 Apr 2027 (estimated)
- Study completion8 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural Sedation and AnalgesiaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A cohort of patients with an indication for DEX sedation for brain NMRI will be included. EEG monitoring will be performed in addition to usual practice, prior to DEX administration and for 20 minutes prior to NMRI, to enable calculation of the PSI sedation score (at 0, 10, 20 minutes). Sedation will also be assessed by the PSSS clinical score at 0, 10, 20 minutes after DEX administration, as well as at 150 minutes after DEX.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Charlotte CULLIER, MD, Principal investigator, CHR Metz Thionville Hopital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867289
- Sponsor's protocol ID
- 2024-02-CHRMT
- Acronym
- DINAMO
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No