Skip to main content
Clinical Trials/NCT04598061
NCT04598061
Unknown
Not Applicable

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

University Hospital, Montpellier1 site in 1 country210 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine IV
Conditions
Newborns
Sponsor
University Hospital, Montpellier
Enrollment
210
Locations
1
Primary Endpoint
duration of motor block
Last Updated
5 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
November 28, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery

Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery

Intervention: Dexmedetomidine IV

Outcomes

Primary Outcomes

duration of motor block

Time Frame: immediately after procedure in the recovery room

Time at which the motor block is finished

Study Sites (1)

Loading locations...

Similar Trials