TREX (secondary analysis)
Trial question
What is the effect of low-dose sevoflurane/dexmedetomidine/remifentanil in children < 2 years of age receiving > 2 hours of general anesthesia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 428
428 patients (133 female, 295 male).
Inclusion criteria: children < 2 years of age receiving > 2 hours of general anesthesia.
Key exclusion criteria: known neurologic, chromosomal, or congenital anomaly likely to be associated with poor neurobehavioral outcome; existing diagnosis of behavioral or neurodevelopmental disability; prematurity; birth weight < 2 kg; congenital heart disease requiring surgery; intracranial neurosurgery or intracranial craniofacial surgery; previous cumulative exposure to general anesthesia > 2 hours.
Interventions
N=207 low-dose sevoflurane/dexmedetomidine/remifentanil (dexmedetomidine at a loading dose of 1 mcg/kg over 10 minutes, then infusion at 1 mcg/kg/hr; remifentanil at a loading dose of 1 mcg/kg over 2 minutes, then infusion ≥ 0.1 mcg/kg/min; goal end-tidal sevoflutane concentration ≤ 0.6-0.8%).
N=221 standard-dose sevoflurane (goal end-tidal sevoflutane concentration ≥ 2.5-3.0%; opioids at the discretion of the anesthetist).
Primary outcome
Intraoperative hypotension
12%
24%
24.0 %
18.0 %
12.0 %
6.0 %
0.0 %
Low-dose
sevoflurane/dexmedetomidine/remifentanil
Standard-dose
sevoflurane
Significant
decrease ▼
NNT = 8
Significant decrease in intraoperative hypotension (12% vs. 24%; ARD -11.6, 95% CI -18.9 to -4.3).
Secondary outcomes
Significant increase in intraoperative bradycardia (24% vs. 5%; AD 18.2%, 95% CI 8.8 to 27.7).
Significant increase in light anesthesia (43% vs. 4%; AD 39.8%, 95% CI 31.1 to 48.5).
No significant difference in median time from eye opening to postanesthesia care unit discharge (59 minutes vs. 55 minutes; MD 1, 95% CI -8.5 to 10.5).
Safety outcomes
No significant differences in postoperative readmission, prolonged hospitalization, serious morbidity.
Conclusion
In children < 2 years of age receiving > 2 hours of general anesthesia, low-dose sevoflurane/dexmedetomidine/remifentanil was superior to standard-dose sevoflurane with respect to intraoperative hypotension.
Reference
Rita Saynhalath, Nicola Disma, Fiona J Taverner et al. Short-term Outcomes in Infants after General Anesthesia with Low-dose Sevoflurane / Dexmedetomidine / Remifentanil versus Standard-dose Sevoflurane (the TREX Trial). Anesthesiology. 2024 Dec 1;141(6):1075-1085.
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