IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

Spinal Anesthesia Clinical Trial

— RACHI_dex  

Official title:

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598061
• Other study ID #: RECHMPL20_0521
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: November 28, 2023

Study information

• Verified date: October 2020
• Source: University Hospital, Montpellier
• Contact: Chrystelle SOLA, PH
• Phone: 06 65 84 91 66
• Email: c-sola[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: November 28, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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...).

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

Related Conditions & MeSH terms

• Infant
• Newborns
• Spinal Anesthesia

Intervention

Drug:
• Dexmedetomidine IV
Dexmedetomidine IV

Locations

Country	Name	City	State
France	University Hospital	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of motor block	Time at which the motor block is finished	immediately after procedure in the recovery room