Double Blinded Study Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The purpose of the study is to determine whether the effect of ondansetron on the analgesic effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen and also reduce opioid consumption
详细描述
The investigators enrolled 80 American Society of Anesthesiologists Physical Status I-II women 18-80 years old scheduled for hysterectomy under general anesthesia over the course of a year. The study will be restricted hysterectomies with horizontal abdominal skin incision who will be able to operate a patient-controlled analgesia (PCA) device.
Participating women will be premedicated with 1-2 mg intravenous (IV) midazolam per preference of the attending anesthesiologist.
Anesthesia will be induced with propofol (2 mg/kg IV); intubation will be facilitated by rocuronium (0.6 mg/kg IV); and anesthesia will be maintained by sevoflurane in combination with nitrous oxide 50% in oxygen. Fentanyl, 2 µg/kg intravenous will be given 3-5 min before the surgical incision.
After endotracheal intubation, all patients' lungs will be mechanically ventilated to maintain the end-expiratory carbon dioxide values between 34 and 36 mmHg.
A Pfannenstiel approach will be used in each woman, and the same surgeon will be conducted all operations.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients 18-80 years old scheduled for hysterectomy
- •Horizontal or vertical abdominal skin incision
- •Ability to operate a patient-controlled analgesia (PCA) device
- •Written informed consent.
排除标准
- •Emergency or urgent procedures
- •Women with pre-existing chronic pain at any site requiring opioid analgesia
- •Who had a history of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- •Significant hepatic (alanine aminotransferase or aspartate aminotransferase >2 times normal) or renal (serum creatinine >2 mg/dl) impairment
- •Allergy to ondansetron or acetaminophen
- •Were pregnant
研究组 & 干预措施
ondansetron
ondansetron iv, 8 mg, skin closure time
干预措施: ondansetron (Drug)
isotonic
isotonic 2ml, once, skin closure time
干预措施: isotonic (Drug)
结局指标
主要结局
Postoperative pain
时间窗: Postoperative 24 hours
Visual analogue scale
Opioid (tramadol) consumption
时间窗: Postoperative 24 hours
Tramadol consumption
次要结局
- Postoperative complications(Postoperative 24 hours)
研究者
Onur Koyuncu
Assistant Proffesor
Mustafa Kemal University