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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborators: Baylor College of Medicine; Boston Children's Hospital; Boston Children’s Hospital; Children's Hospital Medical Center, Cincinnati; Children's Hospital of Philadelphia; Gaslini Children's Hospital; KK Women's and Children's Hospital; Oregon Health and Science University; Princess Margaret Hospital for Children; Starship Children's Health; Sydney Children's Hospitals Network; Sydney Children's Network; Texas Children's Hospital; The Cleveland Clinic; The Royal Children's Hospital Melbourne; UMC Utrecht; University Hospital, Geneva; University of Texas Southwestern Medical Center
• Treatments: Anesthetics; Bupivacaine; Dexmedetomidine; Remifentanil; Ropivacaine

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