Skip to content

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04598061
Acronym
RACHI_dex
Enrollment
210
Registered
2020-10-22
Start date
2020-10-01
Completion date
2023-11-28
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborns, Spinal Anesthesia

Keywords

less than 7 kg, undergoing an infra-umbilical surgery, Spinal anesthesia, Dexmedetomidine, respiratory complications

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.

Interventions

Dexmedetomidine IV

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
duration of motor blockimmediately after procedure in the recovery roomTime at which the motor block is finished

Countries

France

Contacts

Primary ContactChrystelle SOLA, PH
c-sola@chu-montpellier.fr06 65 84 91 66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026