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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353182
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

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
Surgical Procedures, Operative Drug: Dexmedetomidine Drug: Remifentanil Drug: Bupivacaine Drug: Ropivacaine 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.

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Study Type : Interventional  (Clinical Trial)
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 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Ultiva

Drug: Bupivacaine
Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
Other Name: Marcaine

Drug: Ropivacaine
Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)
Other Name: Naropin




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of participants who need for intervention for haemodynamic changes [ Time Frame: 120 minutes (duration of surgery) ]
    1. Rescue treatment for mild Hypotension will be given if MAP is between 40 mmHg and <50 mmHg (confirmed with repeated measure)
    2. Moderate Hypotension will be defined as MAP <40 mmHg
    3. Mild bradycardia will be defined as HR <100 bpm for over one minute
    4. 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



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353182


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Children's Hospital
Houston, Texas, United States, 77030
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Singapore
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
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Principal Investigator: Andrew J Davidson, MD Murdoch Childrens Research Institute
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Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT02353182    
Other Study ID Numbers: 35014
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be presented as group data and no individual will be identified.
Keywords provided by Murdoch Childrens Research Institute:
abdominal
lower extremity
Additional relevant MeSH terms:
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Dexmedetomidine
Remifentanil
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics