Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- incidence and severity of nausea and vomiting
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.
详细描述
- Participants
- 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
- Randomization
- G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
- G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
- G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
- The primary endpoint
- the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
- The secondary endpoints
- the severity of nausea, need for rescue medication
- patient satisfaction with efficacy
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who sign informed consent form for the study
- •patient who are considered as surgical candidates with facial bones fracture
排除标准
- •Patient who have had nausea/vomiting episodes
研究组 & 干预措施
Preop. ramosetron 0.3mg i.v.
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery
干预措施: Ramosetron (Drug)
Postop. ramosetron 0.3mg i.v.
G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
干预措施: Ramosetron (Drug)
No Ramosetron
G3 - No medication but regular antiemetics injection if the patient wants
干预措施: Ramosetron (Drug)
结局指标
主要结局
incidence and severity of nausea and vomiting
时间窗: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
次要结局
- patient satisfaction with the effect(at 24 h after surgery)
研究者
Chan-Yeong Heo
Assistant Professor
Seoul National University Hospital