A COMPARISON OF EFFICACY OF OPIOID FREE ANAESTHESIA USING INTRAVENOUS PARACETAMOL(15MG/KG) VERSUS STANDARD OPIOID ANAESTHESIA USING INTRAVENOUS TRAMADOL(2MG/KG) IN ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of our study will be the 24hour post-operative analgesic consumption in both the groups
研究概览
简要总结
In this study, we will compare post-operative analgesic efficacy of opioid free anaesthesia (OFA) using paracetamol (15mg/kg), lignocaine (2mg/kg) and magnesium sulfate (50mg/kg) verses standard opioid anesthesia (OA) regimen using tramadol (2mg/kg) for preemptive analgesia in Abdominal surgeries under general anaesthesia.PRIMARY OBJECTIVE:
· 24hour post-operative analgesic consumption
SECONDARY OBJECTIVES:
· Quality of analgesia using (numeric rating scale NRS)
· Duration of post-operative analgesia (time for demand of rescue analgesic)
· Effect on hemodynamic parameters intraoperatively (Hypertension/hypotension or tachycardia/ bradycardia).
· Stress response to laryngoscopy at the time of intubation.
· Recovery time (Aldrete score >9)
· QoR-15 (post- operative patient comfort)
· Sedation (Ramsay sedation score)
· Post operative nausea vomiting (PONV)
· Complications like pruritus, respiratory distress, sedation, bradycardia (<50bpm), hypotension (decrease in SBP>30% baseline or <100mm Hg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients posted for elective Abdominal surgery under general anaesthesia.
- •Age between 18 to 65 years.
- •ASA physical status 1 and 2.
排除标准
- •Pregnant or Breastfeeding women Emergency surgery Patients refusal.
- •Patient sensitive / allergic to any of the study drugs.
- •Patients with neuro-psychiatric illness.
- •Cardiovascular disease patients (1 and 2 degree heart block) Patients on beta blockers.
- •Severe bradycardia (HR<50bpm) or LVF.
- •Severe hepatic and renal disease.
结局指标
主要结局
The primary outcome of our study will be the 24hour post-operative analgesic consumption in both the groups
时间窗: Outcome will be assessed at 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 16hr, 20hr and 24hr postoperatively.
次要结局
- Quality of analgesia using( NRS)(Duration of post-operative analgesia)