The Effect of Remimazolam on Postoperative Sleep Quality

NCT ID: NCT07094945

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Remimazolam Grop

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

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

Propofol Group

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Feng Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025S076

Identifier Type: -

Identifier Source: org_study_id