Clinical trial NCT02353182: The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
Official title: An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Procedures, Operative
Keywords: abdominal
lower extremity
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
name: Boston Children's Hospital
name: Oregon Health and Science University
name: Royal Children's Hospital
name: UMC Utrecht
name: Children's Hospital Medical Center, Cincinnati
name: Children's Hospital of Philadelphia
name: Sydney Children's Hospitals Network
name: The Cleveland Clinic
name: Princess Margaret Hospital for Children
name: University Hospital, Geneva
name: Starship Children's Health
name: University of Texas Southwestern Medical Center
name: Gaslini Children's Hospital
name: KK Women's and Children's Hospital
First posted: 2015-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of participants who need for intervention for light anaesthesia
timeFrame: 120 minutes (duration of surgery)
Secondary outcomes:
measure: Number of participants who need for intervention for haemodynamic changes
timeFrame: 120 minutes (duration of surgery)
measure: Time to recovery after anaesthesia
timeFrame: Time from last dressing to: eye opening, removal of airway device, first feed, and a modified Aldrete Score of 9-10 (average 30 minutes-4 hours)
measure: Number of participants who have respiratory complications
timeFrame: Start of anaesthesia until discharge from PACU (average 1-4 hours)
measure: Number of participants who have pain after anaesthesia
timeFrame: End of surgery until discharge from PACU ( average 1-4 hours)
measure: Number of participants who require rescue analgesia in PACU
timeFrame: End of surgery until discharge from PACU (average 1-4 hours)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Andrew J Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: