Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative wound pain score
研究概览
简要总结
The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.
详细描述
The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 19 and 65 years
- •Patients with American Society of Anesthesiologists physical status I or II
- •Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases
- •Patients obtaining written informed consent
排除标准
- •Patients with asthma or hypertension
- •Patients with an inability to express their pain accurately
- •Patients with an inability to understand the pain scale
- •Patients with chronic abdominal pain or chronic pain syndrome
- •Patients who required to convert to laparotomy from laparoscopic surgery
- •Patients who required to receive incidental lower abdominal procedures owing to adhesion, injury, or other incidental findings at the lower abdominal cavity
- •Patients with a history of drug or alcohol abuse
- •Pregnant women
研究组 & 干预措施
Sufentanil
Balanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy.
干预措施: Sufentanil (Drug)
Remifentanil
Balanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Postoperative wound pain score
时间窗: 10 minutes after surgery
The pain score is evaluated by 10 point visual analogue scale at post-anesthesia care unit. The visual analogue scale is presented as a 10-cm line with verbal descriptors indicating "no pain" and "pain as bad as it could be". The visual analogue scale ranges from 0 to 10, representing minimum and maximum pain levels, respectively.
次要结局
未报告次要终点
研究者
Kyoung-Ho Ryu, MD
Assistant Professor
Kangbuk Samsung Hospital