Effect of Dexmedetomidine-esketamine Combination on Sleep Disturbances After Major Noncardiac Surgery: a Single-center, Randomised, Double-blind, Placebo-controlled Trial

What this Trial Is About

Sleep disturbances are common after major surgery and can delay recovery. This trial evaluates whether a combination of dexmedetomidine and esketamine used during general anesthesia and postoperative pain control can reduce sleep disturbances in adults undergoing major noncardiac surgery. The study builds on earlier findings that this drug combination helped improve sleep quality after scoliosis surgery and aims to test this effect more broadly. Participants receive either the dexmedetomidine-esketamine combination or a placebo (normal saline) during anesthesia and afterward as part of patient-controlled intravenous analgesia. The combination is infused before and during surgery, followed by patient-controlled analgesia with specific doses of dexmedetomidine, esketamine, and sufentanil for up to 72 hours after surgery. The placebo group receives saline and sufentanil in similar amounts and timing. During the study, researchers will monitor participants for sleep disturbances within three days after surgery as the primary outcome. They will also assess recovery quality, sleep quality over three nights, pain levels, anxiety and depression on day three, and sleep quality on day 30. The trial involves close monitoring of sleep, pain, and mood, with a follow-up period extending to one month after surgery. The study is randomized, double-blind, and placebo-controlled, ensuring careful evaluation of results.

Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery