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

Study Overview
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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.

Official Title
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An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study

Conditions
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Surgical Procedures, Operative

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Remifentanil
* Drug: Bupivacaine
* Drug: Ropivacaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active open label single arm<br>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: Dexmedetomidine<br>* 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.<br>* Other names: Precedex;Drug: Remifentanil<br>* 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.<br>* Other names: Ultiva;Drug: Bupivacaine<br>* Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)<br>* Other names: Marcaine;Drug: Ropivacaine<br>* Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal, lower extremity