The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:May 2015
End Date:September 2016
Contact:Suzette J Sheppard, BSc (Hons)
Email:suzette.sheppard@mcri.edu.au
Phone:+61 3 9345 4901

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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 50 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.

Inclusion Criteria:

- Infants aged 1 to 12 months (corrected age)

- ASA I or II

- Infants undergoing lower abdominal/lower extremity surgery anticipated to be > 120
minutes in duration

- Surgery requires caudal regional nerve block

Exclusion Criteria:

- ASA III or higher

- Any contraindication to caudal analgesia

- Any contraindication to an inhalational induction with sevoflurane

- Allergies to any medication in study protocol

- Planned admission to an ICU postoperatively (except level II or III neonatal ICU)

- Planned tracheal intubation postoperatively

- Mechanical ventilation postoperatively
We found this trial at
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-456-8559
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-4408
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Phone: 832-826-5831
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Parkville, Victoria 3052
Phone: +61393455233
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