An Evaluation of the Effectiveness of a Single Dose of Preoperative Ginger on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Elective Gynaecological Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of post operative nausea or vomiting
研究概览
简要总结
This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.
详细描述
Postoperative nausea and vomiting (PONV) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. Gynaecological surgery is considered high risk for PONV.
Ginger is a cheap, widely available and safe natural product in Jamaica and has been found to reduce the incidence of Nausea and vomiting in other clinical situations, such as in pregnancy. It is believed to act via the inhibition of serotonergic receptors.
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)
盲法说明
Sequentially numbered, sealed, opaque envelopes prepared and opened the evening before the surgery. Tablets containing either placebo or ginger allocated by a person not involved in any other aspect of the study and administered on the morning of surgery.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above
- •Undergoing elective intra-abdominal, gynaecological surgery
排除标准
- •Allergy to ginger, ginger by-products or cornstarch
- •Gastroesophageal reflux disease (GERD)
- •Allergy to any of the Anaesthesia Agents
- •Inability to swallow capsules.
- •psychiatric illness which prevents patients giving informed consent.
- •Psychological which prevents patients giving informed consent.
研究组 & 干预措施
Placebo
Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.
干预措施: Placebo (Dietary Supplement)
Ginger
Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.
干预措施: Placebo (Dietary Supplement)
Ginger
Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery.
干预措施: Ginger (Dietary Supplement)
结局指标
主要结局
Incidence of post operative nausea or vomiting
时间窗: 12 hours after surgery
The proportion of patient who have any episodes of nausea or vomiting following surgery
次要结局
- Severity of post operative Nausea and vomiting(48 hours after surgery)
- Patient satisfaction(48 hours post surgery)
- Severity of post operative Nausea and vomiting(12 hours after surgery)
- Severity of post operative Nausea and vomiting(24 hours after surgery)
研究者
Patrick J Toppin
Associate lecturer
The University of The West Indies