The Effect of Remimazolam on Postoperative Sleep Quality

Phase 4Not Yet RecruitingNCT07094945

Tongji Hospital260 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

260

Conditions

Gynecological Day Surgery

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Richard Campbell's Sleep Scale score

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

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

Secondary Outcomes

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

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

Time frame: 24 hours after the operation