IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

Last updated: October 16, 2020
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia (Local)

Anesthesia

Treatment

N/A

Clinical Study ID

NCT04598061
RECHMPL20_0521
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Newborns or Infants

  • less than 7 kg

  • Infra-umbilical surgery less than 1 hour

  • Spinal anesthesia

Exclusion

Exclusion criteria:

  • parental refusal

  • Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinalmalformation...).

  • Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolledhemodynamic instability, alertness disorder)

Study Design

Total Participants: 210
Study Start date:
October 01, 2020
Estimated Completion Date:
November 28, 2023

Connect with a study center

  • University Hospital

    Montpellier, Hérault 34000
    France

    Active - Recruiting

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