Comparative study of the analgesic efficacy of intraperitoneal instillation of dexamethasone versus ondansetron as adjuvants to bupivacaine 0.25% in patients undergoing elective laparoscopic cholecystectomy- A prospective randomised double blinded study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Significant reduction in post operative pain in patients who have received 8mg dexamethasone than 4mg ondansetron via intraperitoneal infiltration
研究概览
简要总结
Asses for eligibility , patient will be selected based on the inclusion criteria, will be divided into three groups, Group D will receive 2ml 8mg dexamethasone, group O will receive 2ml of 4mg ondansetron and group c will receive 2ml normal saline along with 30ml 0,25% bupivacaine via intraperitoneal infiltration, general endotracheal anaestheisa will be administered to the patient and the surgery will be done, before extubation drugs will be infiltrated intraperitoneally by the general surgeon through the laparoscopic port over the gallbladder bed and diaphragmatic surface. after extubation postoperative monitoring will be done for pain and PONV, the effectiveness of the drug in reducing the incidence and severity of pain and PONV will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •ASA I-II Surgery duration up to or less than 2 hours.
排除标准
- •Patient using Steroids or NSAIDS Patients with IHD/ Rhythm abnormalities.
- •Patients with significant hepatic, renal or hematological disorders.
- •Patients allergic to study drugs Patients and his/her legally accepted representatives not willing to provide their voluntary written informed consent for participation in the study.
- •Surgery lasting for more than 2 hours If the surgery gets converted to open cholecystectomy Pregnant patients Any patient with postoperative drain Patients with BMI > 30.
结局指标
主要结局
Significant reduction in post operative pain in patients who have received 8mg dexamethasone than 4mg ondansetron via intraperitoneal infiltration
时间窗: IN A TIME PERIOD OF 24 HOURS POST SURGERY
次要结局
- Reduction in postoperative nausea and vomiting(24 hours)