Surgical Procedures, Operative Clinical Trial
Official title:
An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study
Animal studies suggest general anaesthetics harm the developing brain. It is unclear if
these findings are relevant to humans but the issue has become a major concern. Recent data
have found that monkeys exposed to anaesthesia as infants grow up to have slower learning
than those not exposed.
The aim of the TREX pilot study is to determine the feasibility of an alternative
anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of
age.
Animal studies suggest general anaesthetics harm the developing brain. It is unclear if
these findings are relevant to humans but the issue has become a major concern. Recent data
have found that monkeys exposed to anaesthesia as infants grow up to have slower learning
than those not exposed.
The aim of the TREX pilot study is to determine the feasibility of an alternative
anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of
age.
An alternative anaesthetic regimen comprises a dexmedetomidine-based anaesthetic, augmented
with an opioid (remifentanil) and a regional nerve block (such as a caudal).
This open label prospective single arm pilot study will enrol 60 infants aged 1-12 months
scheduled for lower limb, urologic, or lower abdominal surgery. After sevoflurane induction,
the infants will have a caudal anaesthetic and intravenous dexmedetomidine and remifentanil.
The outcome will be need for intervention for light anaesthesia, intervention for
haemodynamic changes and rate of abandoning the protocol. Recovery times will also be
recorded.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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