NCT05215834已完成4 期
The Comparison of Remimazolam With Propofol in Core Body Temperature in Patients Undergoing Robotic-assisted (RARP) and Laparoscopic (LRP) Radical Prostatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- core body temperature change (°C)
研究概览
简要总结
- Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defences in humans are sweating, arteriovenous shunt vasoconstriction, and shivering.
- Inadvertent hypothermia often complicates prolonged surgery. In patients becoming sufficiently hypothermic, reemergence of thermoregulatory vasoconstriction usually prevents further core hypothermia.
- The extent to which anesthetics reduce the vasoconstriction threshold depends on the type of drug and its concentration.
详细描述
- When propofol induces anesthesia, blood pressure decreases due to vasodilation, which is due to direct action on vascular smooth muscle and vasodilation due to blockage of the sympathetic nervous system. This results in a redistribution of body temperature, resulting in hypothermia.
- The effects of remimazolam on the central nervous system, respiratory and cardiovascular system have been studied. Remimazolam, a new type of benzodiazepine drug acts on the GABA-A receptor and has the advantages of rapid induction, rapid recovery, stable hemodynamics, and mild respiratory inhibition. At present, there is little literature on its practice in intraoperative thermoregulation under general anesthesia.
- Investigators hypothesized that the type of anesthetic agents might affect thermoregulatory mechanisms such as the redistribution of body heat, cutaneous heat loss or inhibition of thermoregulatory vasoconstriction. Therefore, Investigators investigated to compare remimazolam with propofol in core body temperature, vasoconstriction threshold and times to onset of vasoconstriction(min)in patients given laparoscopic assisted vaginal hysterectormy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA physical classification I-III,
- •Patients who undergoing Robotic-assisted or laparoscopic (LRP) radical prostatectomy.
排除标准
- •Patients who have Medications or any implanted device that could affect cardiovascular function
- •Patients who have a history with heat imbalance, thyroid diseases, dystautonomia, Raynaud's syndrome, uncontrolled diabetes mellitus, or hypertension.
研究组 & 干预措施
RR group
Experimental
Remimazolam and Remifentanil group
干预措施: Remifentanil (Drug)
PR group
Active Comparator
Propofol and Remifentanil group
干预措施: Remifentanil (Drug)
结局指标
主要结局
core body temperature change (°C)
时间窗: at 60 minutes after induction of general anesthesia
After the induction of general anesthesia, a nasopharyngeal temperature probe was inserted through the nasal cavity, and a 9.5- to 10.0-cm depth was set for optimal placement. The nasopharyngeal temperature was recorded every 10 min until the end of surgery
次要结局
- times to onset of vasoconstriction (minute)(From after induction to until the end of surgery)
- intraoperative hypothermia(From after induction to until the end of surgery)
- Mean arterial pressure (mmHg)(From after induction to until the end of surgery)
- Heart rate (beats/min)(From after induction to until the end of surgery)
- vasoconstriction threshold (°C)(From after induction to until the end of surgery)
研究者
Cheol Lee,MD,PhD,
Professor
Wonkwang University Hospital
研究点 (1)
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