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临床试验/CTRI/2025/09/094353
CTRI/2025/09/094353尚未招募4 期

Perioperative Analgesic Efficacy of Intravenous Infusion of Lidocaine with Ketamine Vs Dexmedetomedine as Opioid Free Anaesthesia (OFA): A Randomised Controlled Trial

Tania bansal1 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5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
To study the effect of infusion of preservative free lidocaine given systemically on analgesic efficacy of infusions of ketamine vs dexmedetomidine

研究概览

简要总结

Opioids have been key components of general anesthesia practice from several decades, attributing to their analgesic, hypnotic effects and ability to provide hemodynamic stability intraoperatively. However opioids are associated with several well recognised side effects such as nausea, vomiting, sedation, ileus, urinary retention, pruritus, confusion, delirium, respiratory depression, increased morphine consumption, immunosuppression, hyperalgesia, chronic postoperative pain, addiction and misuse/abuse. This opioid crisis has questioned our general practice of perioperative use of opioids. Techniques are being developed to avoid these adverse effects. Opioid free anesthesia/ analgesia (OFA) or as is also called, opioid sparing technique (OSS), is an effort or ideology or technique where no intraoperative systemic, neuraxial or intracavitary opioid is administered with anesthesia. It is based on the concept of providing multimodal anesthesia/analgesia (MMA) techniques in order to avoid use of perioperative opioids. With this background in our mind, we decided to test this strategy using intravenous infusions of lidocaine in physiological doses to avoid systemic toxicity with either of the two,  potent and well accepted agents viz; ketamine versus dexmedetomidine.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • ASA Grade 1 and 2 Short to intermediate duration surgeries requiring general anaesthesia.

排除标准

  • Non consenting patients Patients less than 18yrs and more than 65yrs Patients allergic to local anaesthetics Prolonged duration of surgeries more than 2.5 hours.

结局指标

主要结局

To study the effect of infusion of preservative free lidocaine given systemically on analgesic efficacy of infusions of ketamine vs dexmedetomidine

时间窗: T0- At incision baseline | T1- 15 minutes | T2- 30 minutes | T3- 45 minutes | T4- 60 minutes | T5- 90 minutes | T6- 120 minutes | T7- 150 minutes

次要结局

  • To study haemodynamic changes, side effects and complications of infusions of lidocaine added to infusions of ketamine and dexmedetomedine(From incision during surgery under anaesthesia till post operative 24 hours)

研究者

发起方
Tania bansal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Tania bansal

Adesh institute of medical sciences and research bhucho mandi bathinda

研究点 (1)

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