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临床试验/NCT02464722
NCT02464722Unknown4 期

Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia

Korea University Anam Hospital0 个研究点目标入组 50 人开始时间: 2015年8月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
50
主要终点
Change in blood pressure
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. This study is comparing of dexmedetomidine and remifentanil before epinephrine local injection for controlled hypotension during ESS.

详细描述

During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk.

Epinephrine local injection and controlled hypotensive anesthesia is commonly used in several surgical interventions using different techniques. However, choosing the ideal agent is still a controversial topic.

In the current study, the effects and safety of remifentanil, which is an μ opioid receptor agonist and dexmedetomidine, an α-2 agonist; when used before epinephrine local injection for controlled hypotension in ESS, are compared.

After obtaining Institutional Review Board approval and written informed consent, 40 patients is enrolling in this study.

Participants is divided by two groups randomly as the Dexmedetomidine group and the Remifentanil group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •American Society of Anesthesiologist[ASA] class 1-2
  • •scheduled Endoscopic sinus surgery
  • •written informed consent

排除标准

  • •allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
  • •known or suspected upper respiratory infection
  • •suspected difficult tracheal intubation
  • •Uncontrolled Hypertension
  • •known or suspected psychologic disorder
  • •known or suspected significant renal dysfunction
  • •known or suspected severe hepatic dysfunction
  • •known or suspected significant cardiovascular dysfunction

研究组 & 干预措施

Dexmedetomidine

Experimental
  1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes.
  2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done
  4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room.

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine

Experimental
  1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes.
  2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done
  4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room.

干预措施: Epinephrine (Drug)

Dexmedetomidine

Experimental
  1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes.
  2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done
  4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room.

干预措施: Propofol (Drug)

Dexmedetomidine

Experimental
  1. Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes.
  2. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  3. After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done
  4. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room.

干预措施: Rocuronium (Drug)

Remifentanil

Active Comparator
  1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes.
  3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done.
  4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room.

干预措施: Remifentanil (Drug)

Remifentanil

Active Comparator
  1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes.
  3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done.
  4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room.

干预措施: Epinephrine (Drug)

Remifentanil

Active Comparator
  1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes.
  3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done.
  4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room.

干预措施: Propofol (Drug)

Remifentanil

Active Comparator
  1. Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1
  2. Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes.
  3. After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done.
  4. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.
  5. Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
  6. At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room.

干预措施: Rocuronium (Drug)

结局指标

主要结局

Change in blood pressure

时间窗: At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)

次要结局

  • Conditions during Surgery(At the time during Surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joonchul Jang

Resident

Korea University Anam Hospital

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