drugset / Trial / NCT07094945

The Effect of Remimazolam on Postoperative Sleep Quality

NCT07094945

Phase 4 Not yet recruiting 260 enrolled Tongji Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Remimazolam is a new type of benzodiazepine drug and a super-short-acting GABAA receptor agonist. Compared with propofol, remimazolam can largely avoid adverse reactions such as hemodynamic fluctuations, excessive sedation and injection pain caused by propofol. It has good safety and is superior to propofol. However, there are currently only a few clinical research results regarding the impact of remimazolam on the sleep quality of patients under general anesthesia or sedation. Therefore, this study intends to observe the effect of remimazolam on the sleep quality of patients in gynecological day surgery. It is expected that by optimizing the anesthesia plan, the postoperative sleep quality of patients can be improved, and ultimately the postoperative recovery of patients can be promoted.

Timeline

Start
2025-08-15
Primary completion
2026-08-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule 2 mg/kg Intravenous
Subject Remimazolam Small molecule 0.6 mg/kg Intravenous
Subject Remimazolam Small molecule 1 mg/kg Intravenous

Indications

No indication recorded.