IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

• Conditions: Newborns; Infant; Spinal Anesthesia
• Interventions: Drug: Dexmedetomidine IV

• Registration Number: NCT04598061
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-01
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery	Dexmedetomidine IV	Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery

Primary Outcome Measures

Name	Time	Method
duration of motor block	immediately after procedure in the recovery room	Time at which the motor block is finished

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, Hérault, France