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临床试验/NCT02765750
NCT02765750
终止
不适用

Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes

424 General Military Hospital1 个研究点 分布在 1 个国家目标入组 5 人2016年3月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Postoperative Pain
发起方
424 General Military Hospital
入组人数
5
试验地点
1
主要终点
Emergence agitation (yes/no).
状态
终止
最后更新
7年前

概览

简要总结

The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group A and B patients will listen to a positive message under general anesthesia. Group C patients will not listen to the message. The postoperative pain, analgesic consumption and frequency of nausea, vomiting and emergence agitation episodes will be documented and compared between the 3 groups.

注册库
clinicaltrials.gov
开始日期
2016年3月
结束日期
2018年3月
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Georgios Kotsovolis

Dr

424 General Military Hospital

入排标准

入选标准

  • Laparoscopic cholecystectomy.

排除标准

  • Hearing loss.
  • Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines)

结局指标

主要结局

Emergence agitation (yes/no).

时间窗: Within an average of 10 minutes after emergence from general anesthesia.

The patients' mental status will be evaluated with the 7grade Riker's Agitation-Sedation Scale. If the patient has a score of 5 or greater he will be documented as a case of emergence agitation.

Pain Intensity.

时间窗: 24 hours after the end of surgery.

Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing.

Postoperative nausea.

时间窗: 24 hours after emergence from general anesthesia.

The frequency of episodes of nausea will be documented.

Postoperative paracetamol consumption.

时间窗: 24 hours after emergence from general anesthesia.

The patients will be instructed to ask for analgesics as needed. When rescue analgesia is required 1000mg paracetamol will be administered. The frequency of paracetamol administration will be documented.

Postoperative tramadol consumption.

时间窗: 24 hours after emergence from general anesthesia.

If the administration of paracetamol doesn't relieve postoperative pain and the patients continues to ask for analgesia, 100mg tramadol will be administered. The frequency of tramadol administration will be documented.

Postoperative vomiting.

时间窗: 24 hours after emergence from general anesthesia.

The frequency of episodes of vomiting will be documented.

次要结局

  • Explicit memory.(24 hours after emergence from general anesthesia.)

研究点 (1)

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