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

Sponsor
Murdoch Childrens Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02353182
Collaborator
Baylor College of Medicine (Other), Boston Children's Hospital (Other), Oregon Health and Science University (Other), The Royal Children's Hospital Melbourne (Other), UMC Utrecht (Other), Children's Hospital Medical Center, Cincinnati (Other), Children's Hospital of Philadelphia (Other), Sydney Children's Hospitals Network (Other), The Cleveland Clinic (Other), Princess Margaret Hospital for Children (Other), University Hospital, Geneva (Other), Starship Children's Health (Other), University of Texas Southwestern Medical Center (Other), Gaslini Children's Hospital (Other), KK Women's and Children's Hospital (Other)
60
Enrollment
6
Locations
1
Arm
16.1
Duration (Months)
10
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active open label single arm

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants who need for intervention for light anaesthesia [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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 12 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    2 Oregon Health and Science University Portland Oregon United States 97239
    3 The University of Texas Southwestern Medical Center Dallas Texas United States 75390
    4 Texas Children's Hospital Houston Texas United States 77030
    5 Royal Children's Hospital Parkville Victoria Australia 3052
    6 KK Women's and Children's Hospital Singapore Singapore 229899

    Sponsors and Collaborators

    • Murdoch Childrens Research Institute
    • Baylor College of Medicine
    • Boston Children's Hospital
    • Oregon Health and Science University
    • The Royal Children's Hospital Melbourne
    • UMC Utrecht
    • Children's Hospital Medical Center, Cincinnati
    • Children's Hospital of Philadelphia
    • Sydney Children's Hospitals Network
    • The Cleveland Clinic
    • Princess Margaret Hospital for Children
    • University Hospital, Geneva
    • Starship Children's Health
    • University of Texas Southwestern Medical Center
    • Gaslini Children's Hospital
    • KK Women's and Children's Hospital

    Investigators

    • Principal Investigator: Andrew J Davidson, MD, Murdoch Childrens Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murdoch Childrens Research Institute
    ClinicalTrials.gov Identifier:
    NCT02353182
    Other Study ID Numbers:
    • 35014
    First Posted:
    Feb 2, 2015
    Last Update Posted:
    Oct 26, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Murdoch Childrens Research Institute
    abdominal
    lower extremity
    Additional relevant MeSH terms:
    Dexmedetomidine
    Remifentanil
    Bupivacaine
    Ropivacaine

    Study Results

    No Results Posted as of Oct 26, 2016