Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
研究概览
简要总结
The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group.
The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
The secondary outcomes are:
- The severity of post operative nausea and vomiting.
- Use of rescue antiemetic drugs.
- Postoperative pain and sedation.
详细描述
General anesthesia is widely used in several surgeries. It can cause some complications such as postoperative nausea and vomiting (PONV). PONV is more common in general anesthesia than spinal anesthesia. PONV remains an extremely significant challenge due to its complex mechanism, resulting in serious consequences. Therefore an effective way to prevent or arrest PONV is urgently needed as Also, it can cause electrolyte imbalance and aggravate bleeding that delay hospital discharge.
The causes of PONV are multifactorial and can largely be categorized as patient risk factors, anaesthetic technique, and surgical procedure. Antiemetics work on several different receptor sites to prevent or treat PONV.
No single antiemetic pharmaceutical has been provided to be a universal solution to PONV. In general, multimodal combination treatment has superior viability for PONV prophylaxis compared with monotherapy .
Because nausea and vomiting were defined as two separate phe-nomena, studies should report and evaluate the variables distinctly . While since few patients experience vomiting without nausea, the incidence of PONV and postoperative nau¬sea (PON) is fairly similar, thus original papers often do not try to distinguish these variables . So, if PONV but not PON was reported in trails, we considered the PONV variables as a very close substitute for PON; when both PONV and PON were reported simultaneously, we assessed the nausea values. The most com¬monly used time interval to measure the role of antiemetic is 24 hours 6.
Ondansetron is a serotonin receptor antagonist, which is very important in preventing nausea and vomiting due to surgery and chemotherapy; it exhibited an anti-vomiting effect by inhibiting 5-Hydroxytryptamine type 3 (5-HT3) receptors in the vomiting centre .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor)
- The participants will be kept blind in both groups.
- Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •70 Female patients aged between 18 and 65 years
- •ASA I or II
- •patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study.
排除标准
- •Females above 65 years old.
- •patients under 18 years old.
- •ASA > II.
- •Obesity (BMI>40 kgm2).
- •Known hypersensitivity to drugs used in the study protocol.
- •Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease).
- •Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal).
- •Alcoholism or drug abuse.
- •Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before surgery.
研究组 & 干预措施
Dexmedetomidine Group
will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
干预措施: Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . (Drug)
Dexamethasone Group
will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
干预措施: Ondansetron 4mg + dexamethasone 8mg + normal saline. (Drug)
结局指标
主要结局
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
时间窗: through out 24 hours after surgery.
The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.
次要结局
- The severity of post operative nausea and vomiting.(During 24 hours after surgery.)
- - Postoperative pain(During 24 hours after surgery.)
- - Postoperative sedation(During 24 hours after surgery.)
研究者
yasmine mohammed mahmoud mustafa eldeba
Resident doctor of Anaesthesia and ICU Department
Tanta University
