IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants (RACHI_dex)

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

• 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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Anesthesia; Infant; Newborns
• Intervention / Treatment: Drug: Dexmedetomidine IV

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Chrystelle SOLA, PH; Phone Number: 06 65 84 91 66; Email: c-sola@chu-montpellier.fr

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34000
      • Recruiting
      • University Hospital
      • Contact: Chrystelle SOLA, PH; Phone Number: 06 65 84 91 66; Email: c-sola@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery	Drug: Dexmedetomidine IV; Dexmedetomidine IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of motor block	Time at which the motor block is finished	immediately after procedure in the recovery room

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Chrystelle SOLA, PH, UH Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): November 28, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Dexmedetomidine; respiratory complications; less than 7 kg; undergoing an infra-umbilical surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: RECHMPL20_0521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No