Surgical Procedures, OperativePhase 4NCT02353182
The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
A Phase 4 study testing Dexmedetomidine, Remifentanil and Bupivacaine in people with Surgical Procedures, Operative, run by Murdoch Childrens Research Institute at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Surgical Procedures, Operative
- What is being tested?
- Dexmedetomidine, Remifentanil and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Texas Children's Hospital
Houston, Texas, 77030
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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
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.
Read the 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.
- Conditions
- Surgical Procedures, Operative
- Being tested
- Dexmedetomidine, Remifentanil, Bupivacaine, Ropivacaine
- Keywords
- abdominal, lower extremity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
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.
RemifentanilDrug
Also called Ultiva
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.
BupivacaineDrug
Also called Marcaine
Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
RopivacaineDrug
Also called Naropin
Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dexmedetomidine; Drug: Remifentanil; Drug: Bupivacaine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes (duration of surgery)
Secondary outcomes (5)
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
Measured: 120 minutes (duration of surgery)
Time to recovery after anaesthesia
Measured: 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
Any episode of coughing, oxygen desaturation <90%, breath holding > 15 seconds
Measured: Start of anaesthesia until discharge from PACU (average 1-4 hours)
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.
Measured: End of surgery until discharge from PACU ( average 1-4 hours)
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
Measured: End of surgery until discharge from PACU (average 1-4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedures, OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, Boston Children's Hospital, Oregon Health and Science University, Royal Children's Hospital, 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
- Responsible party
- Sponsor
- Investigators
- Andrew J Davidson, MD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353182
- Sponsor's protocol ID
- 35014
- Status last verified
- Oct 2016
- First submitted
- 26 Jan 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be presented as group data and no individual will be identified.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02353182
- Acronym / sponsor ID
- 35014
- Conditions
- Surgical Procedures, Operative
- Keywords
- abdominal, lower extremity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, Boston Children's Hospital, Oregon Health and Science University, Royal Children's Hospital, 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
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active open label single arm | Experimental | Drug: Dexmedetomidine, Drug: Remifentanil, Drug: Bupivacaine, Drug: RopivacaineDexmedetomidine- 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 |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexLoading 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. | Drug | Active open label single arm |
| RemifentanilAlso: UltivaLoading 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. | Drug | Active open label single arm |
| BupivacaineAlso: MarcaineAdministered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist) | Drug | Active open label single arm |
| RopivacaineAlso: NaropinAdministered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist) | Drug | Active open label single arm |
Primary outcome
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.
5 secondary outcomes
Number of participants who need for intervention for haemodynamic changes
Time frame: 120 minutes (duration of surgery)
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)
Number of participants who have respiratory complications
Time frame: Start of anaesthesia until discharge from PACU (average 1-4 hours)
Number of participants who have pain after anaesthesia
Time frame: End of surgery until discharge from PACU ( average 1-4 hours)
Number of participants who require rescue analgesia in PACU
Time frame: End of surgery until discharge from PACU (average 1-4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No. Data will be presented as group data and no individual will be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Davidson, MD principal investigator
Murdoch Childrens Research Institute
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Remifentanil and Bupivacaine in people with Surgical Procedures, Operative, run by Murdoch Childrens Research Institute at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who need for intervention for light anaesthesia (time frame: 120 minutes (duration of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.