Tumor Hospital of Guangxi Medical University, China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- shivering
研究概览
简要总结
Shivering is an early postoperative complication during the postoperative recovery period, and there is no clear consensus about the best way for its prevention. The aim of the study was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with that of parecoxib or placebo for reducing postoperative shivering.
详细描述
154 patients with American Society of Anesthesiologists physical status I-II, who were scheduled for colorectal operation under general anesthesia, were randomly assigned to receive flurbiprofen (Group F), parecoxib sodium (Group P ) or normal saline(Group S)40min before the end of surgery. Hemodynamic parameters were monitored. The occurrence of shivering postoperative nausea and vomiting were recorded during the recovery period. And visual analogue score (VAS) and ramsy sedation scale (RSS) were also recorded.
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
- 21 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One hundred and sixty-six, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the prospective, randomized, double-blind clinical study.
- •All patients who were from 21 to 62 years old and body mass index 19-35 in tumor hospital of Guangxi medical university (State of China) from April 2014 to April 2015 were included.
排除标准
- •Patients with cardiac, pulmonary, hepatic, renal, thyroid, or neuromuscular disease, and those who took chronic drug or abused alcohol were excluded.
- •Another patients with hypertension, gastrointestinal bleeding, an initial core temperature >37.5℃ or <36.5℃, a history of allergy to non- steroidal anti-inflammatory drugs (NSAIDs) or other agents to be used, and inability to cooperate were also excluded in this study.
- •Another patients with blood loss during operation>400ml, a need for blood transfusion during surgery, duration of operation>4h and surgical procedures changed were excluded.
研究组 & 干预措施
Groups Flurbiprofen
Fifty-two, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.
干预措施: flurbiprofen (Drug)
Groups Parecoxib sodium
Fifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.
干预措施: parecoxib sodium (Drug)
Group Saline
Fifty-one, American Society of Anesthesiologists' (ASA) physical status1or2, patients, undergoing colorectal operation were selected in the clinical study.
干预措施: saline (Drug)
结局指标
主要结局
shivering
时间窗: in one hour after extubation.
次要结局
- visual analogue score(at the time of extubation, 30min and 60min after extubation.)
- sedation scores(at the time of extubation, 30min and 60min after extubation.)
- incidence of postoperative nausea and vomiting(in one hour after extubation.)
研究者
xueke du
anesthesiologists
Guangxi Medical University