Study of Remimazolam Combined With Esketamine for Painless Gastroscopy and Colonoscopy in Patients Aged 65 and Older

What this Trial Is About

This clinical trial is studying elderly patients aged 65 and above undergoing painless gastroscopy and colonoscopy to evaluate the use of remimazolam combined with esketamine as an opioid-free anesthesia OFA protocol. Researchers aim to determine if this new protocol is feasible and not inferior to the traditional opioid-containing anesthesia OA protocol using remimazolam combined with remifentanil. The study focuses on comparing sedation success and safety between these two anesthesia methods in elderly patients with gastrointestinal disease. Participants are randomly assigned to one of two groups one group receives anesthesia with remimazolam combined with esketamine, while the other group receives remimazolam combined with remifentanil. Both groups receive initial doses adjusted by body weight during anesthesia induction, with additional doses given during the procedure according to sedation depth and patient movement. The protocol includes drugs such as lidocaine and changtonine alongside the main anesthetics. During the study, researchers will monitor respiratory and circulatory indicators, including oxygen saturation, respiratory rate, heart rate, blood pressure, and sedation levels from the start of anesthesia induction until the end of surgery. They will also record adverse events, recovery times, patient and doctor satisfaction, and cognitive assessments before and after the procedure. Follow-up assessments include telephone interviews and confusion evaluations up to seven days post-surgery to ensure safety and recovery. The trial is planned to continue until January 2028.

Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients