Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
The goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. The main questions it aims to answer are:
- To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the duration of analgesia after hysterectomy surgery
- To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the need for fentanyl after hysterectomy surgery
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-50 years.
- •ASA I and II physical status (American Society of Anesthesiologists).
排除标准
- •The patient is not willing to be included as a research subject
- •The patient takes anti-pain medication before surgery
- •History of allergies to the drugs to be used
- •History of chronic pain
研究组 & 干预措施
Preemptive Ketamine
Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision
干预措施: Ketamine (Drug)
Placebo
Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision
干预措施: Placebo (Other)
结局指标
主要结局
Duration of postoperative analgesia
时间窗: 24 hours post operative
Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA
Total need for post-operative analgesic rescue
时间窗: 24 hours post operative
The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA
次要结局
未报告次要终点