Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Richards-Campbell Sleep Questionnaire (RCSQ) score
研究概览
简要总结
This study aims to evaluate the effect of intraoperative dexamethasone on early postoperative sleep quality in adult patients undergoing nasal surgery under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older undergoing nasal surgery.
排除标准
- •Patients who do not provide informed consent
- •Patients with neurological disease or cognitive impairment that may interfere with questionnaire completion
- •Patients with pre-existing sleep disorders or those taking sleep medications
- •Patients receiving chronic corticosteroid therapy
- •Known hypersensitivity to dexamethasone
- •Patients with glaucoma
- •Patients with poorly controlled diabetes mellitus (HbA1c > 8.0%)
- •Patients with peptic ulcer disease
- •Pregnant or breastfeeding women
- •Patients deemed unsuitable for the study by the investigator (e.g., those requiring postoperative steroid administration for clinical reasons)
研究组 & 干预措施
dexamethasone
Participants in this group will receive intravenous dexamethasone 10 mg during induction of general anesthesia. All other perioperative management, including anesthetic technique and postoperative care, will be conducted according to standard institutional protocols and will be identical to the control group.
干预措施: Dexamethasone (Drug)
placebo
Participants in this group will receive intravenous normal saline (2 mL) during induction of general anesthesia as a placebo. All other perioperative management, including anesthetic technique and postoperative care, will be identical to the experimental group.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Richards-Campbell Sleep Questionnaire (RCSQ) score
时间窗: on postoperative day 1
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported outcome measure. The RCSQ consists of five items evaluating depth of sleep, sleep latency, number of awakenings, efficiency of sleep, and overall sleep quality. Each item is scored on a visual analog scale from 0 to 100, with higher scores indicating better sleep quality.
次要结局
- Quality of Recovery-15 (QoR-15) score(Postoperative day 1)
- sleep efficiency(Postoperative night (day of surgery))
- Incidence of postoperative nausea and vomiting(From end of surgery to postoperative day 1)
研究者
Shin Kyung Won, MD
Doctor
Seoul National University Hospital