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临床试验/NCT03918889
NCT03918889Unknown不适用

A Randomized Controlled Trial of the Effect of Dexmedetomidine Compared With Midazolam on Airway Reflex and Recovery Quality During Emergence From General Anesthesia After Partial and Total Laryngectomy

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
The severity of cough

研究概览

简要总结

Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. Dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. It has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy.

Methods American Society of Anesthesiologists physical status I-II male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(Group D, n = 60) infusion at 0.5 µg•kg-1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg-1•h-1 or midazolam (Group M, n = 60) infusion at 0.05 mg•kg-1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg-1•h-1. The primary outcome measure was the incidence and severity of cough. Hemodynamics, pain intensity [Visual Analogue Scale (VAS)] and Ramsay sedation scale (RSS) were also evaluated at awake, patients returning to ward from post anesthesia care unit (PACU),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Subject scheduled for partial or total laryngectomy.

排除标准

  • Subject has respiratory disease; Subject has pharyngeal paraganglioma; Subject has cardiac disease; Uncontrolled hypertension; Subject has been taking β-adrenoreceptor blockers; Long-term abuse of alcohol (>6 months),opioids, or sedative-hypnotic drugs; Allergic to dexmedetomidine or midazolam; Subject has neuropsychiatric diseases; Operation time shorter than 1 h or longer than 4 h.

研究组 & 干预措施

dexmedetomidine

Experimental

patients receive dexmedetomidine infusion

干预措施: Dexmedetomidine Injectable Product (Drug)

midazolam

Experimental

patients receive midazolam infusion

干预措施: Midazolam injection (Drug)

结局指标

主要结局

The severity of cough

时间窗: Time0:2hours after surgery

Coughing severity was classified using the 3-point scale.:1=mild (single) cough, 2=moderate (≤5 s) cough, and 3=severe (\>5 s) cough.

次要结局

  • SBP(Time7:0 minute after departure from the PACU)
  • the incidence of adverse effects(Time0:2hours after surgery)
  • SpO2(Time7:0 minute after departure from the PACU)
  • BDP(Time7:0 minute after departure from the PACU)
  • Pain intensity(Time0:2hours after surgery)
  • Sedation(Time0: 2hours after surgery)
  • HR(Time7:0 minute after departure from the PACU)
  • DBP(Time6:0 minute after awareness)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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