NCT07094945

The Effect of Remimazolam on Postoperative Sleep Quality

The Effect of Remimazolam on Postoperative Sleep Quality of Patients Undergoing Gynecological Day Surgery

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecological Day Surgery

Interventions

Type	Name	Description
DRUG	Remimazolam	Remimazolam 0.3 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 0.6-1.0 mg/kg·h is used for anesthesia maintenance.
DRUG	Propofol	Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-08-30
• Completion: 2026-09-30
• First posted: 2025-07-31
• Last updated: 2025-07-31