Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale(NRS)
研究概览
简要总结
Although remifentanil provides profound analgesia during operation, postoperative occurrence of hyperalgesia and tolerance after remifentanil administration could be a challenge to the postoperative pain control. Evaluation of analgesia and anti-nociception during anesthesia is still a challenging issue. Surgical Pleth Index (SPI) is a non-invasive and simple access tool used to monitor autonomous nervous system during anesthesia. This technique is based on photoplethysmographic wave and heart beat analysis. SPI values range between 0 (no stress) and 100 (high stress level). The purpose of this study was to determine the appropriate use of Remifentanil for pain control in patients with SPI.
详细描述
Patients were randomized into either SPI-guided analgesia or standard practice (Control). In both groups, anesthesia was maintained with total intravenous anaesthesia(TIVA) to keep bispectral index values between 40 and 60.
In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation.
SPI was recorded before the intubation, after the intubation, directly before the end of surgery. The number of unwanted somatic events, hemodynamics, Patient-controlled analgesia(PCA) consumption, narcotic analgesics consumption, and recovery times were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who received the breast conserving surgery
排除标准
- •Patients with arrhythmia who have poor SPI measurement
- •When the patient refused
- •Patients with decreased renal function of Cr> 2
- •Surgery for more than 3 hours, surgery expected to bleed more than 500 ml
研究组 & 干预措施
Remifentanil gradually withdrawal group
20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.
干预措施: Remifentanil (Drug)
Remifentanil immediately stop group
The control group stopped remifentanil 10 minutes before the end of the operation.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Numeric Rating Scale(NRS)
时间窗: postoperative 1 hour
The difference of postoperative highest pain score (NRS) between two groups
次要结局
- nausea & vomiting(postoperative 1 hour)
- Numeric Rating Scale(NRS)(during postoperative 48hours)
- the duration of eye opening(end of surgery)
- intraoperative remifentanil consumption(intraoperative)
- SPI(intraoperative (after the incision))
- analgesics consumption(up to postoperative 48hours)