Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598061
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-10-06
Brief Title:
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants RACHI_dex
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACHI_dex
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 childs 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 childs 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
Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16 The childs 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 childs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None