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

NCT ID: NCT02353182

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Procedures, Operative

Keywords

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abdominal lower extremity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

Remifentanil

Intervention Type DRUG

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.

Bupivacaine

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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Precedex Ultiva Marcaine Naropin

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Royal Children's Hospital

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Sydney Children's Hospitals Network

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Princess Margaret Hospital for Children

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

Starship Children's Health

UNKNOWN

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Gaslini Children's Hospital

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew J Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Royal Children's Hospital

Parkville, Victoria, Australia

Site Status

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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United States Australia Singapore

Other Identifiers

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35014

Identifier Type: -

Identifier Source: org_study_id