Adverse Anesthesia Outcome
Conditions
Keywords
intraoperative fluid, pediatric, goal directed therapy, pediatric with major abdominal surgery, ASA less than or equal to 3, Duration of surgery less than 2 hours, Body weight more than or equal to 15 kg
Brief summary
The objectives of this study are 1) to investigate the influence of different fluid regimen (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of USCOM monitoring using serum lactate and base deficit as control parameters.
Detailed description
Liberal regimen = maintenance fluid(4/2/1) + deficit fluid + replacement of third space loss (\>,=10ml/kg/h) Goal directed therapy regimen = maintenance fluid + deficit fluid + fluid replaced by hemodynamic monitoring guided.
Interventions
DRUGconventional liberal fluid regimen
Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration
Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1). Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 5 Years
Healthy volunteers
No
Inclusion criteria
* Body weight \< 15 kg * Under going major abdominal surgery such as tumor removal, gut obstruction, pull through, etc. under general anesthesia and invasive arterial pressure monitoring if justified * ASA \< or = 3 * Duration of surgery \> or = 2 hours
Exclusion criteria
* Cardiopulmonary disease * Renal insufficiency * Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation * reoperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with 5% postoperative weight gain between control group and study group | 24 hours | Body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | 4 days | Postoperative morbidity: lung (new postoperative infiltration), prolonged ileus means inability to feed in postoperative day 4, kidney ( increase BUN, Cr), tissue hypoxia (wound infection, anastomotic leakage) |
| Amount of intraoperative fluid | 1 day | Amount of intraoperative fluid |
Countries
Thailand
Contacts
Primary ContactSuwannee Suraseranivongse, MD
Backup ContactSuwannee Suraseranivongse
Outcome results
None listed