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临床试验/NCT02146976
NCT02146976已完成4 期

Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy

China Medical University, China1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
124
试验地点
1
主要终点
The Change of postoperative sleep quality

研究概览

简要总结

The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.

详细描述

The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index score (BIS) was monitored during the operation and the first postoperative night.

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
Single (Participant)

入排标准

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

入选标准

  • Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy

排除标准

  • Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a Pittsburgh Sleep Quality Index global scores higher than 6, had an anesthesia time longer than 4 hours, had a history of cardiovascular, neurological, or psychiatric disease, had cervical lymph node metastasis, were treated with sedative and analgesics during the postoperative BIS-Vista monitoring period, were allergic to drugs used in the study, or had been diagnosed with Graves' disease or hyperthyroidism or hypothyroidism.

研究组 & 干预措施

Propofol

Experimental

introvenious infusion of propofol

干预措施: propofol (Drug)

Inhaled anaesthetic (Sevoflurane)

Experimental

sevoflurane (1.0-1.3% Minimum Alveolar Concentration)

干预措施: sevoflurane (Drug)

结局指标

主要结局

The Change of postoperative sleep quality

时间窗: preoperation, first postoperative night

The primary outcome was the postoperative sleep quality, which was measured by the BIS-Vista monitor on the first night after surgery.

次要结局

未报告次要终点

研究者

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

Wen-fei Tan

Associate Professor

China Medical University, China

研究点 (1)

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