Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Postoperative pain at rest
研究概览
简要总结
The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several animal models. However, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain than those anaesthetized with propofol. And we further posit that the difference is due to the nociceptive processing induced by the action of 5-HT3A receptors.
In this prospective, randomized, double-blind, placebo-controlled study, we assessed the analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •female patients
- •American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- •undergoing selective gynaecological laparoscopies for infertilities
排除标准
- •aged under 18 years old
- •body mass index (BMI) > 30
- •history of cardiovascular disease
- •history of respiratory disease
- •history of neurologic disease
- •history of chronic antidepressants
- •history of anxiolytics
- •history of chronic analgesics intake
- •participating in other studies
研究组 & 干预措施
P+P
干预措施: Group P+P (Drug)
P+T
干预措施: Group P+T (Drug)
S+P
干预措施: Group S+P (Drug)
S+T
干预措施: Group S+T (Drug)
结局指标
主要结局
Postoperative pain at rest
时间窗: At 0.5 postoperative hour
The primary outcome was the postoperative pain at rest assessed by numeric analog score (NAS, where 0 indicates no pain, and 10 indicates the most severe pain) immediately after awaking.
次要结局
- Postoperative pain at rest(At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours)
- Intraoperative hemodynamic values(At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture)
- Postoperative shivering(At 24 hour postoperativelly)
- The incidence of postoperative nausea and vomiting (PONV)(At 24 hour postoperativelly)
- Quality of Recovery Score 40(At 24 postoperative hour)