RACHI_dex: IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04598061
Collaborator
(none)
210
1
37.9
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine IV

Study Design

Study Type:
Observational
Anticipated Enrollment :
210 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery

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

Drug: Dexmedetomidine IV
Dexmedetomidine IV

Outcome Measures

Primary Outcome Measures

  1. duration of motor block [immediately after procedure in the recovery room]

    Time at which the motor block is finished

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Montpellier Hérault France 34000

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Study Director: Chrystelle SOLA, PH, UH Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04598061
Other Study ID Numbers:
  • RECHMPL20_0521
First Posted:
Oct 22, 2020
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2020