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临床试验/NCT04673500
NCT04673500已完成不适用

Comparison of Large Antecubital Vein Versus Small Vein on Dorsum of Hand for the Prevention of Propofol Injection Pain

King Khalid University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Assessment of severity of pain on propofol injection

研究概览

简要总结

Title: Assessment of pain on lidocaine-Propofol admixture injection: Comparing large antecubital vein and small vein dorsum of hand.

  • Objective: To evaluate the pain on Propofol - lidocaine admixture injection using different sizes of veins on upper limb.
  • Design: Prospective randomized clinical trial Place and duration of study: Department of Anesthesia, King Saud University Riyadh May 1, 2013 - May 31, 2014).
  • Patient and methods: Total 160 adult patients were divided in two groups. Age 20-50 years of either gender, American Society of Anesthesiologist (ASA) class 1 and 2, scheduled for elective surgery under general anesthesia were included in the study. Patients with known history of allergy to lidocaine or Propofol, obese patients, anticipated difficult intubation, already on any analgesics and pregnant patients were excluded from the study. Both groups received an admixture of Propofol (1%) - lidocaine (2%) on induction of anesthesia through antecubital vein (Group- 1) or through a vein on dorsum of hand (Group- 2). Pain was assessed as none, mild, moderate or severe. Results: Moderate to severe pain on intravenous injection of Propofol-lidocaine admixture through antecubital vein and small vein on dorsum of hand was 20% vs 71%. Conclusion: There is marked reduction of pain when Propofol - lidocaine admixture was injected through antecubital vein as compared to small vein on dorsum of hand.
  • Key words: Propofol, injection, pain

详细描述

Propofol is the most commonly used drug for induction of anesthesia because of its rapid onset, short duration of action, easy titration and with fewer hemodynamic Effects. Hypersensitivity reaction with Propofol is very rare and reported incidence of pain on injection is 26-70%. As Propofol is extensively used for the induction of anesthesia its pain on injection cannot be neglected. Propofol was launched for clinical practice in 1977 in Cremophor form and reformulation as aqueous solution was launched in 1986, an oil-in water emulsion containing soybean oil. Many interventions have been tried for the reduction of pain on Propofol aqueous solution injection. Unfortunately none of the intervention was found to be successful to abolish the pain completely. So far the mechanism of pain on Propofol injection is not clear.

The everyday uses of Propofol in many settings of the hospitals mandate its painless use. The proposed mechanisms of pain are release of local mediators and / or direct irritant effect of Propofol on nerve endings.

In this study the investigators combined two interventions, Propofol - lidocaine admixture and different size of veins, to evaluate the pain on Propofol injection. The admixture of Propofol-lidocaine was injected through two different sizes of veins which are commonly used for intravenous cannulations, large antecubital vein and small vein on dorsum of hand.

Propofol is a commonly used drug for induction of anesthesia and sedation in intensive care, emergency room and for endoscopic procedures. Unfortunately, despite its popularity pain on its injection is still unresolved problem. The exact mechanism of this pain is not clear so far.

Some investigators suggest that the lipid solvent for Propofol activates the plasma kallikrein-kinin system and produces bradykinin. This modifies the injected local vein causes vasodilation and hyper-permeability. This modification of the peripheral vein may increase the contact between the aqueous phase Propofol and free nerve endings of the vessel resulting in Pain.Others investigators believe that Propofol as a member of phenol group can have direct irritant effect on local vein by stimulating nociceptors and free nerve endings giving rise to an immediate sensation of pain. Based on these assumptions of Propofol induced pain pathway, different investigators postulated different interventions to alleviate this problem. Different pharmacological and non-pharmacological interventions have been tried for the reduction of pain on Propofol injection. The injection of Propofol through large antecubital vein was considered as a superior method than any other non pharmacology measures like changing the temperature of Propofol, large intravenous catheter and speed of injection.Pharmacological interventions with different drugs have been tried, pretreatment with lidocaine with venous occlusion. Propofol-lidocaine admixture, pretreatment with Ketamine, opioids,non-steroidal anti-inflammatory drugs ,magnesium sulfate, ondansetron, tramadol, acetaminophen, dexamethasone and Propofol emulsions containing medium and long chain triglycerides have been studied and reviewed extensively.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The whole arm with the intravenous catheter was covered with a green sheet, from where the mixture of propofol-lidocaine was given.

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 20 to 50 years of either gender
  • ASA ( American Society of Anesthesia) class 1 and 2
  • Scheduled for elective surgical procedure under general anesthesia

排除标准

  • Patients with known history of allergy to lidocaine or Propofol
  • Obese patients
  • Anticipated difficult intubation
  • ASA 3 and 4
  • Already on any analgesics and pregnant patients

研究组 & 干预措施

Propofol-lidocaine through large vein

Experimental

Eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the antecubital fossa and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia.

干预措施: Propofol lidocaine through large vein (Drug)

Propofol-lidocaine through small vein

Placebo Comparator

Another eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the dorsum of hand and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia.

干预措施: Propofol lidocaine through small vein (Drug)

结局指标

主要结局

Assessment of severity of pain on propofol injection

时间窗: From preoperative to day one postoperative

A 20 gauge intravenous catheter was inserted either in large antecubital vein or in a small vein on dorsum of hand. An initial 30% of a mixture of propofol lidocaine was given to assess the severity of pain on propofol injection before the patient sleeps. The pain on propofol injection was assessed by numerical rating scale (NRS). 0-10, where 0 is no pain and 10 is worst pain imaginable

次要结局

  • Heart rate(From base line pre-propofol injection to Intraoperative after full dose of propofol injection.)

研究者

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

Abdul Sattar Narejo

Consultant Anesthetist

King Khalid University Hospital

研究点 (1)

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