NewbornsRACHI_dexNCT04598061
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
An observational study of Newborns and Infant, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia. Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborns, Infant, Spinal Anesthesia
- What is being tested?
- Dexmedetomidine IV
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 28 Nov 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour
Who may be able to join
- Newborns or Infants
- less than 7 kg
- Infra-umbilical surgery less than 1 hour
- Spinal anesthesia
Who cannot join
- parental refusal
- Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
- Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Montpellier, Hérault, 34000
Chrystelle SOLA, PH, 06 65 84 91 66, c-sola@chu-montpellier.fr
About this study
Official title: IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
- Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.
- Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
- The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
- Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
- Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
- The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.
- Conditions
- Newborns, Infant, Spinal Anesthesia
- Being tested
- Dexmedetomidine IV
- Keywords
- less than 7 kg, undergoing an infra-umbilical surgery, Spinal anesthesia, Dexmedetomidine, respiratory complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine IVDrug
Dexmedetomidine IV
| Study group | Role | What they receive |
|---|---|---|
| Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery | Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery Receives: Drug: Dexmedetomidine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of motor block
Time at which the motor block is finished
Measured: immediately after procedure in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion28 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystelle SOLA, PH, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598061
- Sponsor's protocol ID
- RECHMPL20_0521
- Acronym
- RACHI_dex
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
- ClinicalTrials.gov ID
- NCT04598061
- Acronym / sponsor ID
- RACHI_dex / RECHMPL20_0521
- Conditions
- Newborns, Infant, Spinal Anesthesia
- Keywords
- less than 7 kg, undergoing an infra-umbilical surgery, Spinal anesthesia, Dexmedetomidine, respiratory complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 28 Nov 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- 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.
- Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.
- Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
- The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
- Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
- Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
- The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery | – | Drug: Dexmedetomidine IVNewborns or Infants less than 7 kg undergoing an infra-umbilical surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour
Key inclusion criteria (4 listed)
- Newborns or Infants
- less than 7 kg
- Infra-umbilical surgery less than 1 hour
- Spinal anesthesia
Key exclusion criteria (3 listed)
- parental refusal
- Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
- Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)
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 |
|---|---|---|
| Dexmedetomidine IVDexmedetomidine IV | Drug | Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery |
Primary outcome
duration of motor block
Time frame: immediately after procedure in the recovery room
Time at which the motor block is finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Chrystelle SOLA, PH study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborns and Infant, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 3 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 22 Oct 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Chrystelle SOLA, PH (06 65 84 91 66, c-sola@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of motor block (time frame: immediately after procedure in the recovery room). 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 22 Oct 2020.