Intravenous Amisulpride with intravenous Ondansetron versus intravenous Dexamethasone with intravenous Ondansetron in prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) To evaluate the incidence of emetic episodes within 24 hours post-surgery in both treatment groups.
研究概览
简要总结
Post operative nausea and vomiting(PONV) is a common and distressing complication following surgical procedures affecting approximately 20-30% of patients despite advancements in anaesthesia and pre operative care. it is distressing for patients and increases the risk of other adverse events. PONV results from a complex interplay of multiple factors including patients characteristics, surgical factors, anaesthetic agents and preoperative interventions. risk factors such as female gender , history of PONV and motion sickness, non smoking status ,younger age, type and duration of surgery, use of volatile anaesthetics and opioid analgesia
Dexamethasone is a potent corticosteroid with anti inflammatory and immunosupressive properties has emerged as a promising agent for PONV. its ability to modulate multiple pathways involved in pathogenesis of PONV has led to its wide spread use in perioperative care.
Amisulpride is a atypical antipsychotic agent used in treatment of psychiatric disorders such as schizophrenia and bipolar disorder has gained interest in potential role of PONV. studies has shown efficacy of the drug in preventing chemotherapy induced nausea vomiting which shares common pathway with PONV.
The goal of study is the compare the efficacy and safety of intravenous amisulpride with intravenous ondansatron and intravenous dexamethasone with intravenous ondansetron in PONV in patients undergoing elective laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Scheduled to undergo elective laparoscopic cholecystectomy under general anaesthesia lasting for atleast 1 hour under GA with inhalational agent.
- •Ability to provide informed consent for participation in the study.
排除标准
- •Patients with a history of severe adverse reactions to any of the study medications.
- •Known hypersensitivity to any of the study drugs.
- •History of significant cardiac, renal, hepatic, or neurological disorders.
- •Pregnancy or breastfeeding.
- •Use of antiemetic medications within 24 hours prior to surgery.
结局指标
主要结局
1) To evaluate the incidence of emetic episodes within 24 hours post-surgery in both treatment groups.
时间窗: To assess at 1st, 2nd, 6th and 24th hour post-surgery
2) To assess the severity of nausea at 1, 2, 6 and 24 hours post-surgery in both treatment groups using a patient verbal rating scale.
时间窗: To assess at 1st, 2nd, 6th and 24th hour post-surgery
3) To predict the incidence of PONV using the Apfel scoring system in both treatment groups.
时间窗: To assess at 1st, 2nd, 6th and 24th hour post-surgery
次要结局
- To determine the need for rescue medication for PONV in each treatment groups
研究者
Lavanya Parashar
Shri Guru Ram Rai Institute Of Medical And Health Sciences, dehradun