A Comparative Prospective Randomised Double blind Study To Compare Of Quality Of Recovery QoR 15 Following Administration Of Intravenous Lignocaine Versus Fentanyl In Patients Undergoing Functional Endoscopic Sinus Surgery Under General Anaesthesia In SMS Medical College Jaipur
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of Recovery score QoR 15 postoperatively
研究概览
简要总结
This Prospective randomised controlled trial aims to compare the effects of Intravenous Lignocaine versus Intravenous Fentanyl on postoperative recovery qualit in patients undergoing Functional Endoscopic Sinus Surgery FESS Under General anaesthesia Both drugs are commonly used for I trapper active analgesia and modulation of peri operative stress responses
Sixty patients aged 18 to 60 years classified as ASA Physical status I or II scheduled for elective FESS will be randomly allocated into two groups Gruop L will receive intravenous lignocaine 1.5mg/ kg bolus followed by 2mg/kg/hour infusion and Group F will receive Intravenous fentanyl 2 mcg/kg bolus followed by 0.5 mcg/kg/hour infusion till end of surgery
The primary outcome will be the Quality of recovery QoR 15 score at 24 hours postoperatively Secondary outcomes include time to first rescue analgesia with total number of analgesic doses in 24 hours and to assess the Numerical Rating Scale Score at various time intervals between the two study groups and to compare the adverse effects such as nausea vomiting bradycardia hypotension between the two groups
This study seeks to determine whether lignocaine a non opioid analgesic with anti inflammatory and anti hyper Algeria properties can provide superior recovery outcomes compared to the conventional opioid Fentany in ENT surgeries
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed written consent Age 18 to 60 years Elective Functional Endoscopic Sinus Surgery under General anaesthesia ASA GRADE I AND II.
排除标准
- •Known hypersensitivity to local anaesthetics Body mass index greater than 30kg/m2 Patients with clinically significant neurological psychiatric or cardiovascular or renal and hepatic diseases History of alcoholic or drug abuse Patients who received an opioid medication within a 24 hour period before surgery.
结局指标
主要结局
Quality of Recovery score QoR 15 postoperatively
时间窗: At 24 hours
次要结局
- To compare the adverse effects between the two groups if any
- To Compare the postoperative analgesia duration and total number of doses in 24 hours between the two study groups(24hours)
- To assess Numercal rating scale score at various time intervals between the two study groups(At 30mintes 6 hours 12 hours 24 hours)