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NCT Number: NCT07094945

The Effect of Remimazolam on Postoperative Sleep Quality

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.

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Key information

Conditions

Gynecological Day Surgery

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remimazolam

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

Drug

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

Primary outcomes

  1. Richard Campbell's Sleep Scale score

    Time frame: The night of the first to third postoperative day

    Range: 0 points (optimal sleep) to 10 points (optimal sleep). Direction: The higher the score, the more severe the sleep problem

Secondary outcomes

  1. Blood Pressure

    Time frame: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed

  2. Heart rate

    Time frame: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed.

  3. Postoperative adverse reactions

    Time frame: 24 hours after the operation

    such as postoperative pain, nausea, vomiting, and fatigue.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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