CTRI/2025/08/093586尚未招募不适用
Comparative randomised controlled study of PONV(postoperative nausea and vomiting) in laparoscopic cholecystectomy, opioid vs ketamine lignocaine based anesthesia
Dr Haneefa Khan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduced incidence of PONV(post operative nausea & vomiting) in laproscopic cholecystectomy patients without compromising on intraoperative haemodynamic stability of patient.
研究概览
简要总结
- Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24 hours after surgery.
- PONV is one of the most common causes of patient dissatisfaction and unanticipated hospital admission after anaesthesia, with reported incidences of 40% in patients who undergo general anaesthesia and can be up to 80% in high-risk patients.
- The highest risk patients for PONV appear to be young to middle-aged, non-smoking females with a history of PONV or motion sickness (all are independent risk factors).
- It could result in many adverse events such as discomfort, dehiscence of sutures, increased bleeding, esophageal rupture (Boerhaave’s Syndrome), incisional hernia, raised ICP, dehydration if prolonged, metabolic alkalosis with loss of hydrogen, chloride, potassium, sodium and water, gastric content aspiration, pneumonia and esophageal rupture and result in delayed discharge from the hospital.Increased medical costs, and hospital readmission are all common in cases of PONV.
- As the need for ambulatory surgery increases, the prevention of PONV continues to become more important to the system based approach of anesthesiology
- Our aim is to reduce the incidence of PONV in patients undergoing laproscopic cholecystectomy using opioid versus using lignocaine and ketamine during anaesthesia.
- This is a single institutional Prospective randomised control trial involving 100 patients who underwent laparoscopic cholecystectomy for a period of 15 months from September 2025 to December 2026 in Peerless Hospital And B K Roy Research Centre, Kolkata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients who have given informed consent.
- •The Patients of ASA-American Society of Anaesthesiologists Grade I, II.
- •The Patients aged 18 -50yrs.
- •The patients who are electively scheduled for laproscopic cholecystectomy.
排除标准
- •The patients who refused to participate in the study.
- •The patients with ASA Grade 3 and above.
- •Patients aged below 18 and above 50 years.
- •Vestibular disorders, pregnancy and patients with history of chemotherapy.
- •The patients with known hypersensitivity to the local anaesthetics & Opioids.
结局指标
主要结局
Reduced incidence of PONV(post operative nausea & vomiting) in laproscopic cholecystectomy patients without compromising on intraoperative haemodynamic stability of patient.
时间窗: 24 hours
次要结局
- Early Recovery After Surgery
- Patients Comfort During Perioperative Period
- Patients Satisfaction During Perioperative Period.
- Prevention Of Opioid Related Adverse Effects
研究者
Dr Haneefa Khan
Peerless Hospital & B K Roy Research Centre
研究点 (1)
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