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临床试验/NCT03120247
NCT03120247已完成2 期

Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy

Assiut University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年4月5日最近更新:
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
36
试验地点
1
主要终点
Peak Plasma Concentration (Cmax)

研究概览

简要总结

Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.

详细描述

The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic properties, which also make it useful in anesthesia including; decreased MAC, analgesia without respiratory depression and a significant reduction in catecholamine secretion. Also it has been used off-label as an adjunctive agent for sedation and analgesia in patients in the critical care unit and for sedation during non-invasive procedures in radiology. It also has a potential role as part of anesthesia care to prevent emergence delirium and post-anesthesia shivering.

Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.

The current literature is focused in studying the sedative and analgesic effects of intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies undertaken on alternative routes of dexmedetomidine administration are lacking. The pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been demonstrated in one study only, and the clinical effects of non-parenteral administration of dexmedetomidine have been described in anecdotal case reports.

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
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status I - II.
  • Aged between 20 and 60 years.
  • Scheduled for modified radical mastectomy

排除标准

  • Cardiac disease.
  • Hepatic disease.
  • Renal disease.
  • History of alcohol or drug abuse.
  • Patients with a known allergy to the study drug

研究组 & 干预措施

DEX I

Active Comparator

OTM Dexmetetomidine 1µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.

干预措施: OTM Dexmedetomidine 1µg/ kg. (Drug)

DEX II

Active Comparator

OTM Dexmetetomidine0.75µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.

干预措施: OTM Dexmedetomidine 0.75µg/ kg. (Drug)

DEX III

Active Comparator

OTM Dexmetetomidine 0.5µg/kg. Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.

干预措施: OTM Dexmedetomidine 0.5µg/ kg. (Drug)

结局指标

主要结局

Peak Plasma Concentration (Cmax)

时间窗: 360 minutes.

Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)

次要结局

  • Heart rate preoperative(30 minutes)
  • Sedation preoperative(30 minutes)
  • Area under the plasma concentration versus time curve (AUC)(360 minutes.)
  • Blood pressure preoperative(30 minutes.)

研究者

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

Hala Saad Abdel-Ghaffar

Assistant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Assiut University

研究点 (1)

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