Feng Gao, MD, Investigator
Baylor College of Medicine
What is the quality of non-human primate (NHP) studies used to support the concern for anesthesia-related neurodevelopmental delays in children? This poster session describes a systematic review of 18 manuscripts from studies in NHPs at postnatal ages 0 to 40 day with early anesthesia exposure.
Findings show deficits and inconsistencies in study design, execution, and reporting. Problems in study design include a lack of blinding data acquisition and analysis with supra therapeutic maintenance dosing in 28% of studies and a lack of sample size justification in 89% of studies. Critical inconsistencies also appear in or due to 1) documentation of anesthesia provider, 2) electrocardiogram monitoring, 3) continuous arterial blood pressure monitoring, 4) use of spontaneous ventilation, 5) failed intubations with co-mingling of data analysis on ventilated and unventilated animals, 6) poor reporting on survival, and 7) poor reporting on where anesthetics induce brain cell death. Additionally, a majority of behavioral outcomes under investigation are not significantly different from those in the control groups.
Dr. Gao:
“Our study demonstrated that drawing concrete conclusions about anesthesia safety in neonates from neonatal non-human primates is challenging due to the complexity and expense of conducting research with these scarce animals.”
“We found that the design, conduct, and analysis of the primate studies used to support the concern for anesthesia-related neurodevelopmental delay were flawed in many of the same ways that compromised the rodent studies.”
“We hope our work will stimulate stronger rigor, design, reporting, and critical review of animal studies in pediatric anesthesia safety research.”
“We urge the scientific journals and the FDA to apply more stringent criteria to the evaluation of studies such as these and to bring unbiased reviewers and statisticians from outside the field of anesthesiology into the process.”