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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02353182
Ethics application status
Date submitted
26/01/2015
Date registered
2/02/2015

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
Timepoint [1] 0 0
120 minutes (duration of surgery)
Secondary outcome [1] 0 0
Number of participants who need for intervention for haemodynamic changes
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
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
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
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
Sex
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
Not applicable
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
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
60
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
Baylor College of Medicine
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
Government body
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be presented as group data and no individual will be identified.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02353182