跳至主要内容
临床试验/NCT02675049
NCT02675049已完成2 期

Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia

Tianjin Medical University Cancer Institute and Hospital0 个研究点目标入组 100 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
主要终点
pain scores changes by pain NRS scores

研究概览

简要总结

This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

详细描述

Breast lumpectomy associated with a high level of anxiety, fear and pain requires fast and effective anaesthesia techniques. Presently, this procedure is usually performed under general or local anaesthesia. General anaesthesia provides an effective sedation; however, for minor procedures, general anaesthesia is resource-intensive and postoperative complications, such as nausea, vomiting or extended time to ambulation, are more likely. Local anaesthesia alone may be uncomfortable or uncooperative for patients. Therefore, an efficient drug regimen is required that reduces analgesic consumption, minimises opioid-related side effects and shortens post-anaesthesia care unit (PACU) stay following surgery.

Dexmedetomidine (DEX) is a highly selective α2 adrenoreceptor agonist that provides sedation without respiratory depression. Its sedative, anxiolytic, analgesic and haemodynamic effects have made it a useful adjunct to anaesthesia and sedation. DEX may provide a conscious sedation under monitored anaesthesia care (MAC) that is a logical middle ground between general anaesthesia and local anaesthesia. Intranasal DEX was recently shown to provide satisfactory anaesthesia and premedication sedation in healthy volunteers and paediatric patients. The intranasal route is not only effective, but also well-tolerated and convenient This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia, and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

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, 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

入选标准

  • with ASA(American Society of Anesthesiologists) physical status I and II
  • scheduled for breast lumpectomy

排除标准

  • a history of heart block
  • upper respiratory tract infection
  • allergy to DEX or local anaesthetics
  • memory or cognitive dysfunction
  • pregnancy
  • lack of understanding the consent process
  • impaired liver or renal function
  • a history of drug or alcohol abuse

研究组 & 干预措施

0.9% saline

Placebo Comparator

Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.

干预措施: 0.9% saline (Drug)

dexmedetomidine 1 µg.kg-1

Experimental

Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

干预措施: dexmedetomidine 1µg.kg-1 (Drug)

dexmedetomidine 1.5 µg.kg-1

Experimental

Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

干预措施: dexmedetomidine 1.5µg.kg-1 (Drug)

dexmedetomidine 2 µg.kg-1

Experimental

Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

干预措施: Dexmedetomidine 2µg.kg-1 (Drug)

结局指标

主要结局

pain scores changes by pain NRS scores

时间窗: before surgery,during surgery and after surgery for pain scores,assessed up to 2 hours

Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scale

时间窗: before surgery,during surgery and after surgery for sedation changes,assessed up to 2 hours

次要结局

  • Adverse event that is related to treatment:severe sinus bradycardia(perioperative period)
  • Adverse event that is related to treatment:hypotension(perioperative period)
  • Adverse event that is related to treatment:nausea and vomiting(perioperative period)

研究者

申办方类型
Other
责任方
Sponsor

相似试验