The Effect of Remimazolam on Postoperative Sleep Quality

Tongji Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Gynecological Day Surgery

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07094945

2025S076

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA classification grades I - II.
• BMI: 18.5-24 kg/m ².
• Be able to correctly understand and complete the assessment scale independently.
• The operation time shall not exceed one hour.
• Informed consent for this research.

Exclusion criteria

• PSQI > 7 points (with sleep disorders requiring medical intervention within the last month).
• Suffering from central nervous system diseases or mental disorders.
• Patients with sleep apnea syndrome or other serious respiratory diseases.
• Have functional disorders of important organs.
• Alcohol abuse or a history of opioid, benzodiazepine or other known drug abuse that may affect sleep.
• Allergic to the research medication.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups

Remimazolam Grop

Experimental group

Description:

Remimazolam 0.3mg/kg for induction and 0.6-1.0 mg/kg·h for maintenance of anesthesia

Treatment:

Drug: Remimazolam

Propofol Group

Active Comparator group

Description:

Propofol 2 mg/kg for induction and 4-12 mg/kg·h for maintenance of anesthesia

Treatment:

Drug: Propofol