Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- the incidence of Postoperative nausea and vomiting
研究概览
简要总结
As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.
详细描述
Intervention
- Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg,
- Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,
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
- 19 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic gynecological surgery.
- •Adults between the ages of 18 and 50
- •American Society of Anesthesiologists Physical Status (ASA physical status I, II
排除标准
- •American Association of Anesthesiologists physical standards (ASA physical status III or higher)
- •Children under the age of 19
- •Adults over 49 years of age
- •Diabetes Mellitus
- •Pregnant or lactating women
- •Patients with a history of allergy or contraindications for use of the study drug
- •Patients who did not understand this study or expressed their refusal.
- •Patients with a history of serious psychologic disease that may affect the patient evaluation
- •Patients taking serotonergic drugs
研究组 & 干预措施
Dual therapy group
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants.
In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
干预措施: normal saline (Drug)
Triple therapy group
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes.
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
干预措施: fosaprepitant (Drug)
结局指标
主要结局
the incidence of Postoperative nausea and vomiting
时间窗: during 24 hours after surgery
yes or no
次要结局
- the severity of Postoperative nausea and vomiting(during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery)
- rescue antiemetics(during 24 hours after surgery)
- opioid consumption(during 24 hours after surgery)
- Any adverse event(during 24 hours after surgery)
- Qualityof recovery from surgery and anesthesia(during 24 hours after surgery)
- the incidence of Postoperative nausea and vomiting(during post-anesthesia care unit stay, during 6 hours after surgery)
- Time to first flatus(during in hospital stay, an average of 5 days)
- postoperative pain at rest and couging(during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery)
- Time to normal diet(during 24 hours after surgery)
- time to rescue antiemetics(during 24 hours after surgery)
研究者
Heejoon Jeong
Assistant professor
Samsung Medical Center