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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02353182




Registration number
NCT02353182
Ethics application status
Date submitted
26/01/2015
Date registered
2/02/2015
Date last updated
26/10/2016

Titles & IDs
Public title
The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
Scientific 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
Secondary ID [1] 0 0
35014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Procedures, Operative 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dexmedetomidine
Treatment: Drugs - Remifentanil
Treatment: Drugs - Bupivacaine
Treatment: Drugs - Ropivacaine

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


Treatment: Drugs: 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.

Treatment: Drugs: 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.

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants who need for intervention for light anaesthesia - Rescue treatment for light anaesthesia will be given if hypertension MAP > 80 mmHg (confirmed with repeated measure) and/or patient movement.
Timepoint [1] 0 0
120 minutes (duration of surgery)
Secondary outcome [1] 0 0
Number of participants who need for intervention for haemodynamic changes - 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
Timepoint [1] 0 0
120 minutes (duration of surgery)
Secondary outcome [2] 0 0
Time to recovery after anaesthesia
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Number of participants who have respiratory complications - Any episode of coughing, oxygen desaturation <90%, breath holding > 15 seconds
Timepoint [3] 0 0
Start of anaesthesia until discharge from PACU (average 1-4 hours)
Secondary outcome [4] 0 0
Number of participants who have pain after anaesthesia - FLACC (Face, Legs, Activity, Cry, Consolability) scale. The scale is scored in a range of 0-10 with 0 representing no pain.
Timepoint [4] 0 0
End of surgery until discharge from PACU ( average 1-4 hours)
Secondary outcome [5] 0 0
Number of participants who require rescue analgesia in PACU - Analgesia: morphine 0.025-0.05 mg/kg IV for analgesia; repeat 20 minutes. Analgesia thereafter as per local protocol
Timepoint [5] 0 0
End of surgery until discharge from PACU (average 1-4 hours)

Eligibility
Key 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
Minimum age
1 Month
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Singapore
State/province [4] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Texas Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Boston Children’s Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Oregon Health and Science University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Royal Children's Hospital Melbourne
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
UMC Utrecht
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Children's Hospital Medical Center, Cincinnati
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Children's Hospital of Philadelphia
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Sydney Children's Hospitals Network
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
The Cleveland Clinic
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Princess Margaret Hospital for Children
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University Hospital, Geneva
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Starship Children's Health
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
University of Texas Southwestern Medical Center
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Gaslini Children's Hospital
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
KK Women's and Children's Hospital
Address [15] 0 0
Country [15] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02353182
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew J Davidson, MD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications