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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

TypeNameDescription
DRUGDexmedetomidine IVDexmedetomidine 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.