Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- PONV
研究概览
简要总结
This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.
详细描述
Dimenydrinate has been extensively used for motion sickness. However, as far as postoperative nausea and vomiting is concerned the results are still conflicting.
This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old
- •ASA PS I-III
- •Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations
排除标准
- •Refused to participate
- •Age other than 18-75 years old
- •Pregnant patients
- •Non-elective operations
- •Patients that are not able to receive p.os agents
- •Medical history of Brugada Sdr or Brugada-like/related ECG abnormalities
- •Long-Qt Sdr or concurrent use of medications that may cause long-QT ECG abnormalities
- •Medical or family history of psychosis
- •Allergy in dimenydrinate or in dimenydrinate drug versions
- •Perioperative use of dexamethasone
研究组 & 干预措施
Dimenydrinate
Preoperative per os administration of 50 mg dimenydrinate
干预措施: Dimenhydrinate Tablets (Drug)
Ondasentron
Intraoperative intravenous administration of 4 mg ondansetron
干预措施: Ondansetron iv (Drug)
结局指标
主要结局
PONV
时间窗: 24 hours postoperative
PONV recording in patients undergone laparoscopic cholocystectomy
次要结局
- preoperative anxiety(30 minutes before operation)
- Awaken time(on extubation)
研究者
Elena Arnaoutoglou
Professor of anesthesiology
University of Thessaly