IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

NCT04598061 | Unknown

• 1 other identifier: RECHMPL20_0521
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborns; Infant; Spinal Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• duration of motor block

  Time at which the motor block is finished

  immediately after procedure in the recovery room

Study Arms (1)

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

Interventions

Dexmedetomidine IV DRUG

Dexmedetomidine IV

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Newborns or Infants
• less than 7 kg
• Infra-umbilical surgery less than 1 hour
• Spinal anesthesia

You may not qualify if:

• parental refusal
• Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
• Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, Hérault, 34000, France

RECRUITING

Study Officials

• Chrystelle SOLA, PH

  UH Montpellier

  STUDY DIRECTOR

Central Study Contacts

Chrystelle SOLA, PH

CONTACT

06 65 84 91 66; c-sola@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 22, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: November 28, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

FR (1)