A Comparative Study Between Palonosetron vs the Combination of Granisetron and Dexamethasone in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Complete response towards the study drugs
研究概览
简要总结
This is a prospective, randomized, double-blinded study comparing the post-operative nausea vomiting (PONV) profile following administration of intraoperative palonosetron alone and the combination of granisetron and dexamethasone in moderate to high-risk patients undergoing elective laparoscopic cholecystectomy.
Patients aged 18-65 years with American Society of Anesthesiologists physical status I or II were randomized into two groups. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery. The occurrence of PONV and the need for rescue antiemetics were assessed at 30 minutes, 4, 24 and 48 hours post-anesthesia. A complete response towards the study drugs was considered when patients did not experience PONV and did not require rescue antiemetics. The side effects of the study drugs were evaluated. Patient satisfaction with the anti-emetics administered was assessed.
These parameters were compared between Group A and Group B: the occurrence of PONV, the need of rescue antiemetics, the side effects of the study drugs and patient satisfaction with the anti-emetics administered.
详细描述
This prospective double-blinded, randomized controlled study was conducted at Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Malaysia after obtaining approval from the Institutional Ethics Committee of Universiti Kebangsaan Malaysia (UKM).
Patients aged 18 to 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective laparoscopic cholecystectomy under general anesthesia were recruited using convenient sampling. Patients with heart diseases, prolonged QT syndrome, a family history of sudden death, known allergies, or contraindications to the study drugs were excluded. No premedication was administered to the patients, and an intravenous (IV) drip was not started preoperatively.
After obtaining written informed consent, patients were randomized to one of two groups using computer-generated random numbers. Group A received IV palonosetron 0.075 mg, and Group B received IV granisetron 1 mg and IV dexamethasone 4 mg as antiemetics.
Patients were fasted for at least 6 hours prior to surgery. In the operating room, standard monitoring was applied to every patient, including continuous electrocardiography (ECG), non-invasive blood pressure monitoring (NIBP), pulse oximetry, capnography with multi-gas analyzer including minimum alveolar concentration (MAC), and monitoring of all gas levels.
Patients were pre-oxygenated with oxygen. Induction of anesthesia was conducted using IV fentanyl 2 mcg/kg and IV propofol 2 mg/kg. Upon loss of consciousness, IV rocuronium 0.6 mg/kg was administered to facilitate endotracheal intubation, following which patients were mechanically ventilated with a mixture of oxygen and air. Anesthesia was maintained with sevoflurane at MAC of 1.0 to 1.2. Ventilation parameters were adjusted to maintain normocapnia (end-tidal carbon dioxide of 35-40 mmHg) and saturation of oxygen above 96%.
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
- Single (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
- 是
入选标准
- •aged 18 to 65 years old
- •American Society of Anesthesiologists (ASA) physical status I or II
- •scheduled for elective laparoscopic cholecystectomy under general anesthesia
排除标准
- •patients with heart diseases
- •patients with prolonged QT syndrome
- •patients with a family history of sudden death
- •patients with known allergies to dexamethasone, granisetron & palonosetron
- •patients with contraindications to dexamethasone, granisetron & palonosetron
研究组 & 干预措施
Group B
Group B received intravenous (IV) dexamethasone 4 mg after intubation & IV granisetron 1 mg at the end of surgery
干预措施: Dexamethasone, granisetron & palonosetron (Drug)
Group A
Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation.
干预措施: Dexamethasone, granisetron & palonosetron (Drug)
结局指标
主要结局
Complete response towards the study drugs
时间窗: 1 year
Number of patients who did not experience postoperative vomiting, did not experience postoperative nausea \& did not require rescue antiemetics.
次要结局
- The side effects of the study drugs(1 year)