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临床试验/NCT05486819
NCT05486819Unknown早期 1 期

Effect of Lignocaine Versus Sodium Bicarbonate on Reducing Pain Due to Intravenous Injection of Propofol : a Prospective Randomised Double-blinded, Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
180
试验地点
1
主要终点
measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating

研究概览

简要总结

To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI).

详细描述

Propofol is the most commonly used intravenous (IV) anesthetic drug for induction of anesthesia and for sedation. It is almost an ideal IV anesthetic agent, but pain which occur during its injection still remains a problem. This pain may not be a serious complication, but most patients remember it as an unpleasant encounter with anesthetists. In one survey, pain on propofol injection (POPI) stands 7th most important problem in the current practice of anesthesia . About 70 to 90% of patients who were given propofol for anesthesia induction experience pain during injection and this pain can be quite severe. All phenols irritate skin and mucous membranes. Thus, propofol being an alkyl-phenol is expected to induce pain despite the fact that it is almost isotonic. POPI has also been described as angialgia which means that the pain is due to vascular involvement . POPI is immediate as well as delayed after 10-20 seconds . The immediate pain is due to irritation of vein endothelium while as delayed pain is due to the release of mediators such a kininogen from kinin cascade . The most frequently used drug to alleviate POPI is intravenous lignocaine. The use of lignocaine to decrease POPI is due to its local anesthetic effect on the veins. However, it does not alleviate pain effectively in about 40% of the patients treated in this way (2). Administration of sodium bicarbonate was proved to reduce POPI. The proposed mechanism is through increasing sodium ions concentration as well as increasing serum pH through its buffering effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 65 years old.
  • Patients classified as ASA I or II.

排除标准

  • Patients with the history of allergy to propofol or lignocaine.
  • Patients took any medication for analgesia or sedation in the past 24 hours.
  • Body mass index (BMI) more than
  • Patients classified as ASA III & IV. 5 . Severe mental illness

研究组 & 干预措施

Group (L)

Active Comparator

receive 3 ml (60 mg) of lignocaine 2% added to propofol during injection

干预措施: Propofol Injection (Drug)

Group (B)

Active Comparator

receive 3 ml of sodium bicarbonate 8.5% added to propofol during injection

干预措施: Propofol Injection (Drug)

Group (S)

Placebo Comparator

receive 3 ml of normal saline added to propofol during injection

干预措施: Propofol Injection (Drug)

结局指标

主要结局

measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating

时间窗: 5 months

次要结局

  • 1. Pain intensity at any top up doses of propofol. 2. Heart rate: baseline, 5 seconds, 1 minute & 5 minutes after injection. 3. Blood pressure: baseline, immediately after assessing the pain score then 5 minutes later(5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karim Hussein

lecturer of anesthesia , surgical icu and pain management

Cairo University

研究点 (1)

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