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临床试验/NCT06428084
NCT06428084已完成2 期

Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Universitas Padjadjaran1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
38
试验地点
1
主要终点
Nausea and Vomiting Score

研究概览

简要总结

Nausea and vomiting following laparoscopic cholecystectomy remain common, with occurrence rates of 40-70% during the initial 24 hours post-operation. The underlying mechanisms of postoperative nausea and vomiting engage five distinct neurotransmitter receptors. Consequently, employing a combination of antiemetics from diverse classes that target various receptors for effective prevention is advised. Ondansetron's antiemetic properties derive from its ability to inhibit serotonin receptors, whereas Haloperidol targets dopamine receptors, and Dexamethasone reduces prostaglandin production.

详细描述

Postoperative nausea and vomiting (PONV) are also known as the little problem interpreted as a seemingly less significant complication but lead to increased morbidity, longer hospital stays, increased medical costs, and diminished patient satisfaction with healthcare services. These symptoms are reported more frequently than postoperative pain, making its prevention as important as postoperative pain management. In laparoscopic cholecystectomy, the occurrence of PONV can range from 40 - 70%, which is higher than the 33 - 49% observed in other types of surgeries under general anesthesia within the first 24 hours post-procedure. The mechanism of PONV is complex, involving multiple neurotransmitters. Targeted neurotransmitter receptors in the action of antiemetic drugs include muscarinic-1-acetylcholine (M1), dopamine-2 (D2), histamine-1 (H1), 5-Hydroxytryptamine-3-serotonin (5HT3), and neurokinin1-substance P (NK1) receptors. Based on this, the prevention of postoperative nausea and vomiting is recommended using a combination of various groups of antiemetics that work on different receptors. Studies have shown that combining different antiemetic classes is more effective than using a single agent. A meta-analysis study stated that dexamethasone, ondansetron, and droperidol are the most used types of antiemetics alone or in combination. Dexamethasone with a 5HT3 antagonist such as ondansetron is the most used antiemetic combination. Another viable option includes dexamethasone with Butypherone group drugs, such as droperidol, which acts as a D2 antagonist. However, droperidol was subject to FDA black box warnings in 2003 due to its association with arrhythmias caused by QT interval prolongation. Subsequent research has suggested haloperidol, another Butypherone group drug, as a safer alternative to droperidol.

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, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing laparoscopic cholecystectomy
  • aged 18 - 65 years
  • ASA physical status 1 and 2
  • Apfel score ≥2

排除标准

  • a history of allergies
  • routine use of antipsychotic drugs, steroids, antihistamines, and antiemetics before surgery
  • cardiac rhythm disorders
  • elevated liver enzyme levels (SGOT/SGPT) ≥5 times upper limit normal
  • BMI ≥35 kg/m2
  • Dropout Criteria:
  • if they experienced hypotension, defined as systolic blood pressure below 90 mmHg or mean arterial pressure (MAP) below 60 mmHg, or a decrease in systolic blood pressure and/or MAP greater than 20% from baseline for a duration exceeding two minutes, surgical procedures extending >3 hours, and any alterations in the planned surgical intervention.

研究组 & 干预措施

Ondansetron

Active Comparator

19 participants in group O received 4 mg of ondansetron intravenously.

干预措施: Ondansetron (Drug)

Haloperidol

Active Comparator

19 participants in group H received 1 mg of Haloperidol intravenously.

干预措施: Haloperidol (Drug)

结局指标

主要结局

Nausea and Vomiting Score

时间窗: 24 hours post-operation

Score 0 (No nausea, no vomiting); Score 1 (Nausea present, no vomiting); Score 2 (Nausea present, vomiting present); Score 3 (Vomiting \>2 episodes in 30 minutes)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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