The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Incidence of Nausea and Vomiting
研究概览
简要总结
This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.
详细描述
Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary osteoarthritis, knee
- •Scheduled for elective total knee arthroplasty
- •Signed written informed consent
排除标准
- •Refusing participate
- •Contraindication to regional anesthesia
- •Severe impairment of bowel motility
- •administration of other antiemetic drug within 24hours before surgery
- •systemic steroid within 24hours before surgery
- •history of cardiovascular & respiratory disease
- •renal & hepatic failure
研究组 & 干预措施
Dexamethasone
dexamethasone 10 mg administration 1 hour before surgery
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of Nausea and Vomiting
时间窗: within 72 hours after surgery
A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting
次要结局
- Pain Level(6 to 24 hours after surgery)
- Wound Complication(within 30 days after surgery)
研究者
Tae Kyun Kim
Direcor, Joint reconstruction center, SNUBH
Seoul National University Hospital