Gynecological Day Surgery
Conditions
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.
Interventions
DRUGRemimazolam
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.
DRUGPropofol
Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Richard Campbell's Sleep Scale score | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 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 | 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 | 24 hours after the operation | such as postoperative pain, nausea, vomiting, and fatigue. |
Outcome results
None listed