跳至主要内容
临床试验/NCT05752903
NCT05752903已完成4 期

Comparison Between Dexmedetomidine-Propofol and Ketamine-Propofol Administration for Sedation of CT Guided Bone Biopsy: A Randomized Controlled Trial

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Heart rate

研究概览

简要总结

This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy.

详细描述

Assessment of boney lesions is an common activity in the care of cancer patients. CT guided Percutaneous needle biopsies have a low complication rate. usually, this procedure is done under sedation.

Propofol is a non-barbiturate hypnotic and sedative. It facilitates gamma-aminobutyric acid mediated inhibitory neurotransmission. It's known to have anti-emetic, antipruritic, anticonvulsant and amnestic effects. Despite being effective and potent, Propofol's main disadvantages is its dose-dependent hypotension and respiratory depression .Ketamine is a phencyclidine derivative which acts as a N-methyl-D-aspartate (NMDA) receptor antagonist. It is a dissociative anesthetic and provides some analgesia. It maintains airway reflexes and spontaneous respiration. Combining Propofol and ketamine preserves the sedative and analgesic efficacy while reducing their adverse effects. Dexmedetomidine is a highly selective α2-agonist. It is eight times more specific compared with clonidine. It has a perioperative anxiolytic, sedative properties as well as some analgesic properties .Dexmedetomidine is usually used for mild to moderate sedation and Propofol could be added to deepen the level of sedation

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, Care Provider)

入排标准

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

入选标准

  • Stated willingness to comply with all study procedures and availability for the duration of the study .
  • Age between 18 to 60 years old
  • American Society of Anesthesiologists (ASA) physical I-III
  • Scheduled for CT guided bone biopsy with sedation.

排除标准

  • Severe heart, lung, and liver disease
  • kidney failure
  • Bleeding diathesis Allergy to drugs to be used

研究组 & 干预措施

Dexmedetomidine-propofol

Active Comparator

Dexmedetomidine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure

干预措施: Dexmedetomidine-propofol (Drug)

ketamine-propofol

Active Comparator

ketamine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure

干预措施: Ketamine-Propofol (Drug)

结局指标

主要结局

Heart rate

时间窗: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively

change in heart rate

次要结局

  • Mean arterial blood pressure(before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively)
  • Visual analogue scale (VAS) score for pain(every 15 minutes for one hour postoperatively)
  • recovery time(immediately postoperative)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验