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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started May 2015

Geographic Reach

3 countries

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

January 26, 2015

Completed

7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed

Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

January 26, 2015

Last Update Submit

October 24, 2016

Conditions

Surgical Procedures, Operative

Keywords

abdominallower extremity

Outcome Measures

Primary Outcomes (1)

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.
120 minutes (duration of surgery)

Secondary Outcomes (5)

Number of participants who need for intervention for haemodynamic changes
120 minutes (duration of surgery)
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)
Number of participants who have respiratory complications
Start of anaesthesia until discharge from PACU (average 1-4 hours)
Number of participants who have pain after anaesthesia
End of surgery until discharge from PACU ( average 1-4 hours)
Number of participants who require rescue analgesia in PACU
End of surgery until discharge from PACU (average 1-4 hours)

Study Arms (1)

Active open label single arm

EXPERIMENTAL

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: DexmedetomidineDrug: RemifentanilDrug: BupivacaineDrug: Ropivacaine

Interventions

DexmedetomidineDRUG

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.

Also known as: Precedex

Active open label single arm

RemifentanilDRUG

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.

Also known as: Ultiva

Active open label single arm

BupivacaineDRUG

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

Also known as: Marcaine

Active open label single arm

RopivacaineDRUG

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

Also known as: Naropin

Active open label single arm

Eligibility Criteria

Age1 Month - 12 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Sites (6)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Interventions

DexmedetomidineRemifentanilBupivacaineRopivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesAnilidesAmidesAniline CompoundsAmines

Study Officials

Andrew J Davidson, MD
Murdoch Childrens Research Institute
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 2, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing: Will not share

Locations

AU(1)SG(1)US(4)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Active open label single arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Active open label single arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations