This double-blind, randomised, controlled trial (n=200) aims to investigate the effect of esketamine on reducing postoperative anxiety and depression in adolescent patients.
Conducted by Henan Provincial People’s Hospital, the study involves adolescents aged 8-17 years undergoing elective surgery under general anaesthesia for at least 2 hours. Participants will be randomly assigned to receive either esketamine or normal saline before the procedure. Vital signs data and inflammatory indicators will be collected during surgery, with anxiety and depression evaluated one month post-surgery.
Inclusion criteria include age between 8 and 17 years, planned elective surgery under general anaesthesia for at least 2 hours, and ASA grade I-II. Exclusion criteria involve severe consciousness disorders, mental system diseases, congenital heart disease, and contraindications to esketamine. The study began in October 2023 and is expected to conclude by February 2025.
Trial Details
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vital signs data, serum IL-6, CRP and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. To determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after surgery.Trial Number NCT06073015