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临床试验/CTRI/2025/09/095467
CTRI/2025/09/095467尚未招募4 期

Efficacy of intraoperative magnesium and vitamin C in the reduction of severity of pain in immediate postoperative period

Department of Anaesthesiology and Critical Care PGIMS Rohtak , Haryana ,India,1240011 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月24日最近更新:

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

发起方
Department of Anaesthesiology and Critical Care PGIMS Rohtak , Haryana ,India,124001
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rajmala Jaiswal

Pt BD Sharma University of Health Sciences Rohtak

研究点 (1)

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