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临床试验/NCT01774305
NCT01774305已完成4 期

Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
141
试验地点
1
主要终点
Coughing Grade

研究概览

简要总结

Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.

In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

排除标准

  • Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean

研究组 & 干预措施

dexmedetomidine

Experimental

We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.

干预措施: Dexmedetomidine (Drug)

saline

Placebo Comparator

We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.

干预措施: Saline (Drug)

结局指标

主要结局

Coughing Grade

时间窗: from the time of eye opening to 5 min after extubation

The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).

次要结局

  • Emergence Time(from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min))

研究者

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

Jeong Soo Lee

Yonsei university college of medicine

Yonsei University

研究点 (1)

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