NCT04598061
Unknown
Not Applicable
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
Overview
- Phase
- Not Applicable
- Intervention
- Dexmedetomidine IV
- Conditions
- Newborns
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- duration of motor block
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery
Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery
Intervention: Dexmedetomidine IV
Outcomes
Primary Outcomes
duration of motor block
Time Frame: immediately after procedure in the recovery room
Time at which the motor block is finished
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Regional AnaesthesiaAnesthesia, ObstetricNCT06055101Reham Ali Abdelhaleem Abdelrahman54
Unknown
Phase 3
IV Dexmedetomidine in the Duration of Spinal Anesthesia With Hyperbaric Bupivacaine: Double Blind Randomized Trial.AnesthesiaDexmedetomidineNCT05335655Hospital Central "Dr. Ignacio Morones Prieto"60
Completed
Phase 4
Postpartum Women's Dexmedetomidine SedationCesarean SectionNCT02111421Guangzhou General Hospital of Guangzhou Military Command60
Unknown
Not Applicable
Optimal Single Dose Intrathecal Dexmedetomidine for Postoperative AnalgesiaLower Limb SurgeryNCT02660658Mansoura University15
Completed
Not Applicable
Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative StudyBenign Prostate HyperplasiaBladder TumorNCT01665586Yonsei University82