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NCT Number: NCT02353182

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

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.

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Key information

Conditions

Surgical Procedures, Operative

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Children's Hospital, Parkville, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Remifentanil

Drug

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

Bupivacaine

Drug

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

Other names: Marcaine

Ropivacaine

Drug

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

Other names: Naropin

Primary outcomes

  1. Number of participants who need for intervention for light anaesthesia

    Time frame: 120 minutes (duration of surgery)

    Rescue treatment for light anaesthesia will be given if hypertension MAP > 80 mmHg (confirmed with repeated measure) and/or patient movement.

Secondary outcomes

  1. Number of participants who need for intervention for haemodynamic changes

    Time frame: 120 minutes (duration of surgery)

    • Rescue treatment for mild Hypotension will be given if MAP is between 40 mmHg and <50 mmHg (confirmed with repeated measure)
    • Moderate Hypotension will be defined as MAP <40 mmHg
    • Mild bradycardia will be defined as HR <100 bpm for over one minute
    • Significant bradycardia will be defined as <70 bpm over one minute

  2. Time to recovery after anaesthesia

    Time frame: 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)

  3. Number of participants who have respiratory complications

    Time frame: Start of anaesthesia until discharge from PACU (average 1-4 hours)

    Any episode of coughing, oxygen desaturation <90%, breath holding > 15 seconds

  4. Number of participants who have pain after anaesthesia

    Time frame: End of surgery until discharge from PACU ( average 1-4 hours)

    FLACC (Face, Legs, Activity, Cry, Consolability) scale. The scale is scored in a range of 0-10 with 0 representing no pain.

  5. Number of participants who require rescue analgesia in PACU

    Time frame: End of surgery until discharge from PACU (average 1-4 hours)

    Analgesia: morphine 0.025-0.05 mg/kg IV for analgesia; repeat 20 minutes. Analgesia thereafter as per local protocol

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Baylor College of Medicine
  • 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
  • Royal Children's Hospital
  • Starship Children's Health
  • Sydney Children's Hospitals Network
  • The Cleveland Clinic
  • UMC Utrecht
  • University Hospital, Geneva
  • University of Texas Southwestern Medical Center

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2015
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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