Comparative Evaluation of Intraoperative Anti-Nociception Efficacy With Opioid Anaesthesia (Fentanyl) vs Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, Lignocaine) in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To evaluate and compare the intraoperative anti nociception efficacy with
研究概览
简要总结
This randomized, single-blinded clinical study aims to compare the intraoperative anti-nociception efficacy of opioid-based anaesthesia using fentanyl versus opioid-free anaesthesia using ketamine, lidocaine, and dexmedetomidine in patients undergoing laparoscopic cholecystectomy. The study design is Randomized, comparative, single blinded study and a total of 54 patients (27 in each group) will be enrolled and divided into two groups randomly. The primary outcome will be assessed using Surgical Pleth Index (SPI) values in response to surgical pain stimulation following skin incision. Secondary outcomes include heart rate, mean arterial pressure, lacrimation, sweating, postoperative pain scoring, analgesic requirements, postoperative nausea and vomiting, time to PACU discharge, intraoperative drug consumption, and awareness assessment. The goal is to evaluate whether opioid-free anaesthesia provides comparable analgesic efficacy while minimizing opioid-related side effects.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient scheduled for laparoscopic cholecystectomy Age between 18 to 60 years ASA grade I and II Both genders Duration of surgery less than and equal to two hours.
排除标准
- •BMI more than 30 kg per meter square Patient having history of drug allergy to Ketamine and Lignocaine or Dexmedetomidine History of usage of opioids and any other analgesics Pregnant females History of psychiatric illness History of endocrine disease-diabetes mellitus and thyroid disease, History of CNS, Cardiovascular or renal disease.
结局指标
主要结局
To evaluate and compare the intraoperative anti nociception efficacy with
时间窗: Perioperative till 24 hours.
opioid versus opioid free anaesthesia (Ketamine, lidocaine and Dexmedetomidine) by change in SPI in response to surgical noxious stimulation following skin incision till 24 hours.
时间窗: Perioperative till 24 hours.
次要结局
- 1) To evaluate & compare the intraoperative anti nociception efficacy with opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard(to:-)
研究者
Dr Arushi Saxena
School of Medical Sciences and Research, Sharda University