跳至主要内容
临床试验/CTRI/2024/09/073695
CTRI/2024/09/073695进行中(未招募)不适用

A comparative study of clinical efficacy of pretreatment between intravenous Granisetron and intravenous Lignocaine to allaevate pain on Propofol injection during general anaesthesia.

Dr Nitin S Kunnoor1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
intravenous granisetron, being a potent 5HT3antagonist might decrease pain (by 50%) caused by iv injection of propofol

研究概览

简要总结

Propofol, a non-opioid intravenous anaesthetic agent, is frequently used as an inducing agent in general anaesthesia. Direct irritant effect of propofol on vein and kinin cascade release causes the pain in 30%-90% of the patients during intravenous injection (IV) though its pH and osmolality are close to those of blood.1,2

The American anaesthesiogist had ranked pain induced by propofol injection as the 7th most common problem of current clinical anaesthesiology.3 Various methods have been tried for attenuating pain during i.v. injection of propofol. Non pharmacological methods like injection in a fast running i.v. fluid, injection in a larger vein, diluting with 10% intra lipid, cooling propofol to 4°C have been tried with little success.4,5

Amongst pharmacological methods pre-treatment with several agents have been tried like lignocaine, fentanyl, ketamine, dexamethasone, dexmetomidine, clonidine, ketoprofen, tramadol.6-9

But, Neither a single agent nor any method is found till date that has 100% efficacy to relieve the pain of propofol injection. Pretreatment with IV lignocaine has proven to be efficacious, by reducing propofol induced pain by nearly 50-60% but is associated with paresthesia that lasts far beyond the duration of anesthesia, sensations of numbness, swelling, tingling, and itching.2

Injection pain is not only a cause of concern but, Post Operative Nausea and Vomiting (PONV) incidences are also high in patients undergoing general surgeries.10, 11 Other peri-operative factors like haemodynamic stability, analgesia andreduced adverse effects to drugs administered are subject of interest to anesthesiologists for better patient care who undergo surgery under general anaesthesia.

In this context, new pharmacological agents like 5HT3 receptor antagonists (ondansetron) have been tried to preventpain on IV propofol injection along with added benefit of preventing PONV, analgesia and reduced parasthesia.12Granisetron, a higher congener of ondansetron, has betterantiemetic effect. The preliminary evidence suggests that granisetron is effective in preventing pain on IV propofol administration by multifaceted activities such as a sodium channel blocker and μ opioid agonist apart from 5HT3 receptor antagonist activity. 10,13,14

 In our practice, 5HT3antagonists like ondensetron and granisetronis routinely administeredas pre-medication to prevent post-operative nausea and vomiting in patients undergoing surgeries under general anaesthesia.

Hence, in this study we want to compare the analgesic efficacy between IV granisetron (2mg in 2 ml) and IV lignocaine 2% (40mg in 2 ml) in allevating pain on IV propofol injection.

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, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants scheduled for elective surgeries under General Anaesthesia (GA)
  • Participants with American Society of Anaesthesiologists (ASA) physical status Grade I & II
  • Age 18-60 years, weighing between 40 – 80 kgs of all genders.

排除标准

  • Emergency surgeries under GA
  • Participantswith history of allergy to specified drugs and its congeners in study.
  • Participants received any sedatives, analgesics within last 12 hours before procedure
  • Pregnant and lactating women
  • Participants with communication problems & Psychiatric Disorder.

结局指标

主要结局

intravenous granisetron, being a potent 5HT3antagonist might decrease pain (by 50%) caused by iv injection of propofol

时间窗: 8 hours

次要结局

  • Reduction in post operative nausea and vomiting up to 8 hours(Haemodynamic changes ; ADR)

研究者

发起方
Dr Nitin S Kunnoor
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nitin S. Kunnoor

Mahadevappa Rampure Medical College and Hospital

研究点 (1)

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