This webpage will inform professionals about the TREX-SAFETY-kids study. In this randomized clinical study the short- and long term effects in children of dexmedetomidine will be researched. Research shows that currently used anaesthetics are neurotoxic, especially when administered in children younger than 2 years of age for a longer period (>2,5h). Both in animal and human research neurological effects of anaesthetics are seen: behavioural problems, memory impairment and learning deficits. These results lead to an official FDA warning: the use of anaesthetics is neurotoxic, so the use of these medicine should be carefully used in young children and pregnant women (see: this PDF).
A possible alternative to this neurotoxic anaesthetics is the sedative dexmedetomidine, an alpha-2 adrenoceptor agonist. When administered with remifentanil and (minimal) sevoflurane, the state of anaesthesia can be reached. Animal studies show less to none neurological risks of the use of dexmedetomidine. However, clinical evidence in humans is not available.
Aim of the study is to compare short term and long term effects of standard anaesthesia with anaesthesia by dexmedetomidine and remifentanil. Children can be included if they are younger than 2 years of age and will be anesthetised for 2,5h or more (when not meeting exclusion criteria). Children will be randomly placed in 1 of the 2 study groups: group 1 will receive standard treatment: anaesthesia by use of sevoflurane. Group 2 will receive the new treatment: dexmedetomidine with remifentanil and (minimal) sevoflurane. Short term effects will be measured during and short after anaesthesia, describing the effects of dexmedetomidine on vitals when administered. All children will be tested for the long term effects when they are 3, 5 and 8 years of age. Tests will be neuropsychological, in order to map the effects of the medicine on behaviour, memory and learning. Parents are asked to fill in some questionnaires concerning the behaviour and development of their child. At 8 years of age, we will perform a MRI-scan, in order to compare neurological activity as well.