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

Murdoch Childrens Research Institute

Status and phase: Completed; Phase 4

Conditions: Surgical Procedures, Operative

Treatments: Drug: Bupivacaine; Drug: Dexmedetomidine; Drug: Remifentanil; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02353182

35014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Active open label single arm

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Remifentanil

Drug: Dexmedetomidine

Drug: Bupivacaine