Comparison of Pre-emptive Flupirtine with Pregabalin for Postoperative Analgesia in Laparoscopic Cholecystectomy - A Randomized Control Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare oral Flupirtine and Pregabalin in terms of postoperative analgesia by visual analogue scale.
研究概览
简要总结
The selected patients will be randomly allocated to one of the following two groups irrespectiveof age or gender. Randomization will be achieved by using random number tables.Group A: Flupirtine- 30 patients will receive oral Flupirtine 200mg 2h prior to the induction of anaesthesia with sips of waterGroup B: Pregabalin- 30 patients will receive 150 mg oral pregabalin about 2h prior to the induction of anaesthesia with sips of water
patients will be visited in their respective wards on the day before the surgery for preanesthetic check-up. After a thorough history, general and systemic examination will be performed, and their laboratory data will be reviewed. Before proceeding for the study, written and informed consent will be taken from the patients scheduled for surgery. On the morning of the surgery, patients will be visited in the preoperative ward about 2h before the induction of anaesthesia and depending on their position in the random number tables, they will be given one of the two oral drugs (pregabalin or flupirtine) with sip of water by an anaesthesiologist not involved in the study before transferring to the operation room.
The patient will be pre medicated with Inj Glycopyrrolate 0.2mg and Inj Midazolam 1mg; induced with Inj Fentanyl 2mcg/kg and Inj Propofol 2mg/kg and orotracheal intubation facilitated by Inj Vecuronium 0.1mg/kg. Anaesthesia will be maintained with air, O2 and Sevoflurane 2%. Supplemental vecuronium will be given as per requirement. All patients will be given a single IV dose of antiemetic, Inj ondansetron 4 mg and Inj Paracetamol 1g. After surgery Inj glycopyrrolate 0.01mg/kg + Inj Neostigmine 0.05mg/kg to be given as reversal. After extubation and ensuring adequate ventilation, patients will be transferred to the post operative room.
Post operative analgesia and sedation will be assessed using Visual Analog Score (VAS score) and Ramsay sedation score (RSS) and noted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patients willing to give informed consent 2)Patient undergoing elective laparoscopic cholecystectomy under general anaesthesia 3)ASA physical status 1 and 2.
排除标准
- •Patients with history of allergy to the studied medications • Patients with a history of psychiatric disorders or presently on analgesic or opioid medication within 28days of scheduled surgery • Pregnancy • Alcohol abuse • Patients with history of liver, kidney, heart disease • Patients with chronic pain on medication.
结局指标
主要结局
To compare oral Flupirtine and Pregabalin in terms of postoperative analgesia by visual analogue scale.
时间窗: post operative analgesia will be assessed using vas scale at intervals of 30mins until patient receives rescue analgesic.
次要结局
未报告次要终点
研究者
MOHAMMED ISMAIL NABEEL
Sapthagiri Institue of Medical Sciences and Research centre