Trials / Unknown
UnknownNCT04598061
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 210 (estimated)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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%. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexmedetomidine IV | Dexmedetomidine IV |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2023-10-01
- Completion
- 2023-11-28
- First posted
- 2020-10-22
- Last updated
- 2020-10-22
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04598061. Inclusion in this directory is not an endorsement.