Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
研究概览
简要总结
The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years old ASA I-II patients
- •Clinical diagnosis of gastroesophageal reflux patients
排除标准
- •Allergic reactions to NSAIDs or opioid analgesics
- •Body mass index exceeding 35
- •Pregnancy
研究组 & 干预措施
dexketoprofen trometamol
Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.
干预措施: dexketoprofen trometamol (Drug)
tramadol hydrochloride
Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.
干预措施: tramadol hydrochloride (Drug)
pethidine hydrochloride
Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.
干预措施: pethidine hydrochloride (Drug)
dexketoprofen trometamol + tramadol hydrochloride
干预措施: dexketoprofen trometamol + tramadol hydrochloride (Drug)
dexketoprofen trometamol + pethidine hydrochloride
干预措施: dexketoprofen trometamol + pethidine hydrochloride (Drug)
vitamin c
干预措施: vitamin c (Drug)
结局指标
主要结局
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
时间窗: postoperative 2 hours
次要结局
未报告次要终点
研究者
GOKHAN GOKMEN
Anesthesiologist, MD
Kavaklıdere Umut Hospital