CompletedInterventionalPhase 2Phase 3Updated Jan 15, 2019
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants | NCT04598061 | Trialant
Unknown statusObservationalUpdated Oct 22, 2020
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
ClinicalTrials.gov ID
NCT04598061
Lead Sponsor
University Hospital, MontpellierOTHER
Overall Status
Unknown status
Study Type
Observational
Enrollment
210Estimated
Last Update Posted
Oct 22, 2020Actual
Start Date
Oct 1, 2020Actual
Primary Completion Date
Oct 1, 2023Estimated
Completion Date
Nov 28, 2023Estimated
Official Title
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
Brief 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.
Newborns
Infant
Spinal Anesthesia
Dexmedetomidine IV
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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...).