NCT02353182

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

An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Surgical Procedures, Operative

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Loading dose:1 mcg/kg over 10 minutes. Infusion: Start 1-1.5 mcg/kg/hr. Titrate up or down within 50% of starting doses as needed.
DRUG	Remifentanil	Loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2-0.5 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed.
DRUG	Bupivacaine	Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
DRUG	Ropivacaine	Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-02-02
• Last updated: 2016-10-26

Locations

6 sites across 3 countries: United States, Australia, Singapore