Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- NRS Pain = Numeric Rating Scale (0-10)
研究概览
简要总结
The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.
Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.
详细描述
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects.
The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.
The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.
The study is including patients undergoing hemorrhoidectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of disc prolapse
- •ASA (American Society in Anesthesiology) I-II
- •written consent
排除标准
- •Age < 18
- •ASA > II
- •liver failure
- •renal failure
- •heart failure
- •pregnancy
研究组 & 干预措施
Placebo
Saline 0,9%
干预措施: Placebo (Drug)
S (+) Ketamine
干预措施: S (+) Ketamine (Drug)
结局指标
主要结局
NRS Pain = Numeric Rating Scale (0-10)
时间窗: 24 hours
The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
次要结局
未报告次要终点