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The Effect of Remimazolam on Postoperative Sleep Quality

NCT07094945 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-07-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094945 on ClinicalTrials.gov