Participants
liver/kidney dysfunction, airway abnormality, allergy
ALLERGY, OBSTRUCTIVE SLEEP APNEA SYNDROME
This prospective, randomized, single-blind study was approved by the ethics committee of by the Medical Ethics Committee of Shanghai Children’s Medical Center (SCMCIRB-K2020058-2) and registered in the Chinese Clinical Trial Registry Network (ChiCTR2100044551) on 24/03/2021. Inclusion of children with CHD was decided by the randomized number generated by computer simulation without sex limitation. Before signing the informed consent form, the guardians were informed of the possible risks associated with sedation and the precautions for care and monitoring.Included in this prospective study were 34 children with CHD, aged from 4 to 54 months and weighing from 5.5 to 20.5 kg, who underwent elective surgery for CHD in March 2021. The exclusion criteria were: American Society of Anesthesiologists (ASA) classification ≥ IV; allergy to the drug to be tested; severe liver/kidney dysfunction; increased intracranial pressure; inability to separate from parents/guardians; history of intranasal surgery; front facial deformity; airway abnormality; and the presence of obstructive sleep apnea syndrome. According to the requirements for the research design of the sequential method, 6–8 crossover points were expected to be included [