Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Emergence agitation (yes/no).
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)
研究组 & 干预措施
BIS 40-60
Patient with intraoperative Bispectral Index (BIS) 40-60.
干预措施: Intraoperative positive messages (Behavioral)
BIS 20-40
Patient with intraoperative Bispectral Index (BIS) 20-40.
干预措施: Intraoperative positive messages (Behavioral)
Placebo
Placebo group
干预措施: No message (Behavioral)
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.)
研究者
Georgios Kotsovolis
Dr
424 General Military Hospital