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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| Boston Children's Hospital | OTHER |
| Oregon Health and Science University | OTHER |
| Royal Children's Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who need for intervention for haemodynamic changes |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Davidson, MD | Murdoch Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States | ||
| Oregon Health and Science University |
Data will be presented as group data and no individual will be identified.
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| OTHER |
| UMC Utrecht | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Sydney Children's Hospitals Network | OTHER |
| The Cleveland Clinic | OTHER |
| Princess Margaret Hospital for Children | OTHER |
| University Hospital, Geneva | OTHER |
| Starship Children's Health | UNKNOWN |
| University of Texas Southwestern Medical Center | OTHER |
| Gaslini Children's Hospital | OTHER |
| KK Women's and Children's Hospital | OTHER_GOV |
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|
| Remifentanil | 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 | Drug | Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist) |
|
|
| Ropivacaine | Drug | Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist) |
|
|
| 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 | Any episode of coughing, oxygen desaturation <90%, breath holding > 15 seconds | 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. | 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 | End of surgery until discharge from PACU (average 1-4 hours) |
| Portland |
| Oregon |
| 97239 |
| United States |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077208 | Remifentanil |
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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