Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- incidence (%) of postoperative nausea and vomiting
研究概览
简要总结
To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.
详细描述
Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting.
Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.
排除标准
- •Central or peripheral neurological pathologies.
- •History of drug abuse, chronic pain, or psychiatric disorders.
- •Pregnant women
- •Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.
研究组 & 干预措施
dexamethasone
intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;
干预措施: dexamethasone (Drug)
gapabentin
oral gabapentin 600 mg 1 hour before induction of anesthesia
干预措施: dexamethasone (Drug)
gapabentin
oral gabapentin 600 mg 1 hour before induction of anesthesia
干预措施: Gabapentin (Drug)
Aprepitant
aprepitan 80mg 1 hour before induction of anesthesia.
干预措施: dexamethasone (Drug)
Aprepitant
aprepitan 80mg 1 hour before induction of anesthesia.
干预措施: Aprepitant (Drug)
结局指标
主要结局
incidence (%) of postoperative nausea and vomiting
时间窗: 24 hours postoperative
The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.
次要结局
- side effects(24 h postoperative.)
- non invasive blood pressure(intra-operative from induction of general anesthesia till end of surgery.)
- heart rate(Intra-operative from induction of anesthesia till end of surgery.)
研究者
Hala Saad Abdel-Ghaffar
MD
Assiut University