Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Postanaesthetic shivering incidence and score
研究概览
简要总结
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.
详细描述
Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 year-old
- •ASA class I, II, and III
- •patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h
排除标准
- •duration of surgery less than 1h or more than 3 h
- •allergy to dexmedetomidine
- •vasoactive antidepressant or analgesics
- •obesity (BMI>30)
- •pregnancy
研究组 & 干预措施
Group I
Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane
干预措施: dexmedetomidine 0.25 µg/kg IV (Drug)
Group II
Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane
干预措施: dexmedetomidine 0.5 µg/kg IV (Drug)
Group III
Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane
干预措施: dexmedetomidine 1 µg/kg IV (Drug)
Group IV
Patients in Group IV will receive same volume of normal saline at closure of sevoflurane
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Postanaesthetic shivering incidence and score
时间窗: change from baseline every 10 minutes up to 1 hour post-operatively
Quality of emergence from anesthesia
时间窗: Change from baseline every 5 minutes till extubation
The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation
次要结局
- Nausea and vomiting(every 10 minutes up to 1 hour post-operatively)
- Time to extubation, awakening and orientation(1 hour post-operatively)
- Pain scores(every 10 minutes up to 1 hour post-operatively)
- Patient's Temperature(every 10 minutes up to 1 hour post-operatively)
- Sedation scores(every 10 minutes up to 1 hour post-operatively)
研究者
Dr. Marie Awad
Professor of Clinical Specialty
American University of Beirut Medical Center