Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Postoperative bleeding
研究概览
简要总结
The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital staying).
详细描述
Smooth emergence from general anaesthesia after surgery is important to prevent potentially dangerous effects such as hypertension, tachycardia, myocardial ischaemia, arrhythmias and increased intracranial and intra-abdominal pressure. After thyroidectomy, activities during emergence such as agitation or coughing, signs of hypertension or tachycardia, or etc. may lead to postoperative bleeding, resulting in acute airway obstruction or reoperation.
The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia and postoperative outcome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient,
- •Aged 20-60 yr,
- •ASA physical status 1-2,
- •Patients undergoing elective thyroidectomy under general anesthesia
排除标准
- •Sighs of difficult airway,
- •History of respiratory disease or chronic cough,
- •Cardiovascular disease,
- •Pregnant or breast-feeding woman
研究组 & 干预措施
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Desflurane (Drug)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Remifentanil (Drug)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Thyroidectomy (Procedure)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Vital signs (Other)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Cough reflex (Behavioral)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Ramsay Sedation Scale (Behavioral)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Extubation time and Recovery time (Other)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Visual analogue scale (Behavioral)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Postoperative bleeding (Other)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Postoperative complications (Other)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Time to remove drainage and duration of hospital staying (Other)
Dexmedetomidine (Group D)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued.
Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Dexmedetomidine (Drug)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Desflurane (Drug)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Remifentanil (Drug)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Thyroidectomy (Procedure)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Vital signs (Other)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Cough reflex (Behavioral)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Ramsay Sedation Scale (Behavioral)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Extubation time and Recovery time (Other)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Visual analogue scale (Behavioral)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Postoperative bleeding (Other)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Postoperative complications (Other)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Time to remove drainage and duration of hospital staying (Other)
Normal Saline (Group N)
After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy.
Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs.
Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued.
After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative bleeding
时间窗: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Postoperative bleeding: Sum of bleeding via barovac
次要结局
- Extubation time(During the recovery time of anesthesia, an expected average of 20 min)
- Recovery time of anesthesia(During the recovery time of anesthesia, an expected average of 20 min)
- Duration of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Ramsay Sedation scale(During the recovery time of anesthesia, an expected average of 20 min)
- Pain score(From the end of surgery to the 3rd postoperative day (an expected average of 3 days))
- Incidence of postoperative complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Coughing Response(During the recovery time of anesthesia, an expected average of 20 min)
研究者
Ki Tae Jung
Assist Professor
Chosun University Hospital