Surgical Procedures, Operative
Conditions
Keywords
abdominal, lower extremity
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.
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.
Interventions
DRUGDexmedetomidine
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.
DRUGRemifentanil
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.
DRUGBupivacaine
Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
DRUGRopivacaine
Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)
Sponsors
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
Murdoch Childrens Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who need for intervention for light anaesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who need for intervention for haemodynamic changes | 120 minutes (duration of surgery) | 1. Rescue treatment for mild Hypotension will be given if MAP is between 40 mmHg and \<50 mmHg (confirmed with repeated measure) 2. Moderate Hypotension will be defined as MAP \<40 mmHg 3. Mild bradycardia will be defined as HR \<100 bpm for over one minute 4. Significant bradycardia will be defined as \<70 bpm over one minute |
| 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) | Any episode of coughing, oxygen desaturation \<90%, breath holding \> 15 seconds |
| Number of participants who have pain after anaesthesia | End of surgery until discharge from PACU ( average 1-4 hours) | FLACC (Face, Legs, Activity, Cry, Consolability) scale. The scale is scored in a range of 0-10 with 0 representing no pain. |
| Number of participants who require rescue analgesia in PACU | End of surgery until discharge from PACU (average 1-4 hours) | Analgesia: morphine 0.025-0.05 mg/kg IV for analgesia; repeat 20 minutes. Analgesia thereafter as per local protocol |
Countries
Australia, Singapore, United States
Outcome results
None listed