COMPARISON OF OPIOID FREE WITH OPIOID BASED ANAESTHESIA IN ELECTIVE DILATATION AND CURETTAGE: A RANDOMISED TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To determine if opioid free anaesthesia is effective
研究概览
简要总结
Acute post operative pain is a concern.Inadequate pain control can result in the patient dissatisfaction,prolonged hospital stays and increased morbidity.Opioid free anaesthesia refers to the perioperative utilisation of opioid sparing technique for intraoperative hemostasis leading to complete avoidance of intraoperative opioids without causing any patient discomfort .Dilatation and curettage is one of the most common gynaecological procedure.Opioid free anaesthesia using iv lidocaine is not much in practise .In order to see the efficacy of opioid free anaesthesia using iv lidocaine this study has been proposed .
Group A (n=90) will be receiving iv lidocaine (1.5mg/kg) slow iv push over a period of 2 minutes at least 5 minutes prior to onset of surgery.
Group B(n=90) will be receiving iv fentanyl (0.75mcg/kg) slow iv push over a period of 2 minutes at least 5 minutes prior to onset of surgery.
Both the groups will be receiving iv diclofenac sodium (75mg) given by slow iv 5 minutes prior to onset of surgery .Following which patient will be positioned for dilatation and curettage. After positioning a sleep dose of propofol will be given . Nitrous oxide and oxygen will be given in ratio of 1:1 via standard face mask of appropriate size. Before injection of drugs vitals will be taken . Intraoperative blood pressure,heart rate ,respiratory rate will be monitored and total cumulative dosage of propofol will be calculated .The patient wil be monitored for post operative pain by VAS scoring at 5mins15mins and 30mins .Patient will be observed for any rescue analgesia ( iv fentanyl 25mcg ) required .
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient willing to give written informed consent to be a part of the study.
排除标准
- •Patient refusal to provide consent.
- •Patient with history of psychotropic medications or psychological disorders.
- •Patient with morbid obesity.
- •Patient allergic to any of the study drugs, use of medications or nutraceuticals that affects blood pressure or heart rate.
- •Surgical procedure exceeding 1 hour duration.
- •Patient with unexpected bleeding complications.
结局指标
主要结局
To determine if opioid free anaesthesia is effective
时间窗: Pain score based on visual analogue scale 5mins 15mins 30mins
次要结局
- To determine the efficacy of opioid free anaesthesia when compared to opioid based anaesthesia in tackling perioperative pain(Pain score based on comparative visual analogue scale 5mins 15mins 30mins)
研究者
DR SWETA PANNA MISHRA
BOKARO GENERAL HOSPITAL