Trial | NCT02353182  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
Study Started
May 31
2015
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2016
Last Update
Oct 26
2016
Estimate

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.

  • Other names: Precedex

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.

  • Other names: Ultiva

Drug Bupivacaine

Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)

  • Other names: Marcaine

Drug Ropivacaine

Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)

  • Other names: Naropin

Active open label single arm Experimental

Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery. Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist

Criteria 

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
No Results Posted