Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Subjective Level of Postoperative Nausea
研究概览
简要总结
Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. However, its effect has not been validated for scleral buckling surgery, which is used to treat retinal detachment, a medical emergency that can lead to permanent blindness. In this study, the investigators will randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo to the other half. The investigators will then compare the postoperative symptoms of the two groups in order to determine whether dexamethasone should be used for scleral buckling surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-79 years old
- •Scheduled for scleral buckle surgery to treat a retinal detachment
- •Consent to participate in study
排除标准
- •Pregnant or nursing
- •Prior treatment with steroids
- •Severe diabetes mellitus (HbA1c > 8%)
- •Use of opioids, sedatives, or any kind of analgesics <1 week before scleral buckling surgery
- •History of alcohol or drug abuse
研究组 & 干预措施
Dexamethasone
Subjects receive intravenous intraoperative dexamethasone
干预措施: Dexamethasone Sodium Phosphate Injection (Drug)
Saline solution
Subjects receive intravenous intraoperative normal saline solution
干预措施: Saline Injection (Drug)
结局指标
主要结局
Subjective Level of Postoperative Nausea
时间窗: At 1 and 7 days post-surgery
Assessed through patient survey, measured by 10cm visual analogue scale
Subjective Level of Postoperative Pain
时间窗: 1 and 7 days post-surgery
Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale
次要结局
- Subjective rating of post-operative lid edema(At 1 and 7 days post-surgery)
- Subjective rating of postoperative chemosis(1 and 7 days post-surgery)