Efficacy of intraoperative magnesium and vitamin C in the reduction of severity of pain in immediate postoperative period
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Severity of postoperative pain as measured on VAS scale (0-10) in immediate postoperative period at 0 hour (in recovery room) followed by at every 10 minutes over the next 3 hours
研究概览
简要总结
All patients will be subjected to the pre-anaesthetic assessment prior to enrollment in the study. Their detailed medical and surgical history will be taken along with any previous anaesthetic exposure with its outcome. A thorough airway, systemic examination will also be done. All patients scheduled for surgery will be kept fasting for at least 6 hours prior to surgery. Randomization will be done by using computer generated numbers into three groups; Group 1 study group (n=30)- patients receiving intravenous vitamin C 3 grams in 100 ml NS, Group II study group (n=30)- patients receiving intravenous magnesium sulphate 2 grams in 100 ml NS, Group III control group (n=30) - patients receiving normal saline. The study drug will be prepared and administered by anaesthesia resident who is not further involved in study. After extubation, postoperative pain will be assessed using VAS scale (0-10) by anaesthesia resident who is involved in the study. Other observations includes time to request for 1st dose of rescue analgesia (i.v Tramadol 1mg/kg) followed by 0.25 mg/kg every 10 minutes over next 3 hours to reduce VAS to 4, time interval between administration of study drug to time to request for first dose of rescue analgesia, total dose of Tramadol, side effects.
研究设计
- 研究类型
- Interventional
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 on agr group 18 to 60 years of either sex belonging to ASA I and II will be included in study who will undergo upper limb orthopedic surgery under general anaesthesia.
排除标准
- •Unwillingness of patient to participate in study, history of chronic pain, opioid or analgesic abuse, Cardiovascular disease, respiratory, neuromuscular, renal and hepatic disease, anaemia, dyselectrolytemia and massive blood loss, major oncosurgeries, duration of surgery more than 3 hours, pregnant and lactating women, previous history of allergy to study drug.
结局指标
主要结局
Severity of postoperative pain as measured on VAS scale (0-10) in immediate postoperative period at 0 hour (in recovery room) followed by at every 10 minutes over the next 3 hours
时间窗: Severity of postoperative pain as measured on VAS scale (0-10) in immediate postoperative period at 0 hour (in recovery room )followed by at every 10 minutes over the next 3 hours
次要结局
- Time to request for first dose of rescue analgesia(I.V Tramadol 1 mg/kg) over 3 hours in recovery room(Time interval after administration of study drug to time to request for 1st dose of rescue analgesia.)
研究者
Dr Rajmala Jaiswal
Pt BD Sharma University of Health Sciences Rohtak
