RACHI_dex: IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
Study Details
Study Description
Brief Summary
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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.
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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.
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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
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Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
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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.
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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 |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- duration of motor block [immediately after procedure in the recovery room]
Time at which the motor block is finished
Eligibility Criteria
Criteria
Inclusion criteria:
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Newborns or Infants
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less than 7 kg
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Infra-umbilical surgery less than 1 hour
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Spinal anesthesia
Exclusion criteria:
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parental refusal
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Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
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Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- RECHMPL20_0521