Spinal Anesthesia Clinical Trial
— RACHI_dexOfficial 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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | November 28, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion criteria: - Newborns or Infants - less than 7 kg - Infra-umbilical surgery less than 1 hour - Spinal anesthesia Exclusion criteria: - parental refusal - Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...). - Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder) |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | duration of motor block | Time at which the motor block is finished | immediately after procedure in the recovery room |
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