The Effect of Remimazolam on Postoperative Sleep Quality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Gynecological Day Surgery. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Remimazolam on Postoperative Sleep Quality of Patients Undergoing Gynecological Day Surgery
Overview
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.
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
Primary outcome measures
- Richard Campbell's Sleep Scale score [Time frame: The night of the first to third postoperative day]
Secondary outcome measures (3)
- 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]
- 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.]
- Postoperative adverse reactions [Time frame: 24 hours after the operation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07094945 · 2025S076