Effect Of Patient Awareness About Possibility Of Occurrence Of Pain During Propofol Injection On The Rate Of Incidence And Severity Of Pain During Injection ; A Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Pain assessment
研究概览
简要总结
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration.
However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .
Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.
详细描述
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration .
However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .
The mechanism of propofol injection pain has not been known yet, but many factors are involved that include the intrinsic drug property (e.g. emulsion composition, pH of the formulation, temperature, injection volume and osmolarity) .
As the lipid solvent irritates the venous intima and triggers a local kallikrein kinin cascade by discharging bradykinin and inflammatory factors, and injection pain occurs when peripheral nerve endings are directly exposed to propofol .
Other factors, including the site of injection, speed of injection, vein size, blood buffering, sex and simultaneous use of different drugs, seem to affect the incidence and severity of propofol injection pain .
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
- Single (Participant)
盲法说明
Double-Blinded
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged 20 to 40 years of The American Society of Anesthesiologists (ASA) I-II , who will be undergoing elective surgery under general anesthesia
排除标准
- •patient with mental illness, poor understanding or difficulty in communication or pain assessment .
- •any organ dysfunction, neurological disease, diabetes mellitus .
- •patient with high education level (patient with education level after high secondary school) .
- •patient with Body Mass Index (BMI) < 18 or > 30
- •allergy to the study drugs .
- •history of chronic pain or those taking regular analgesics, anti-inflammatory drugs pre-operatively .
- •history of drug abuse and other contraindication for lidocaine such as severe bradycardia, Wolf-Parkinson-White syndrome, and other tachyarrhythmias .
研究组 & 干预措施
Patients aware about propofol injection induced pain
Patients who will be informed about the possibility of incidence of propofol injection pain
干预措施: Awareness about propofol injection induced pain (Behavioral)
Patients not aware about propofol injection induced pain
Patients will not be informed about the possibility of incidence of propofol injection pain
干预措施: Awareness about propofol injection induced pain (Behavioral)
结局指标
主要结局
Pain assessment
时间窗: During first 10 seconds after receiving first dose of propofol
Pain intensity will be measured by Verbal categorical scoring (VCS) Verbal categorical scoring (VCS) is a 4-point pain scale: 0-no pain, 1-mild pain with no behavioral sign, 2-moderate pain accompanied by a behavioral sign, and 3-severe pain with a strong vocal response accompanied by facial grimacing, arm withdrawal, or crying ( Jeon Y ,2012).
次要结局
- Age(Preoperative visit)
- Weight(Preoperative visit)
研究者
Mahmoud Hussein Bahr
Associated Professor of Anesthesiology and Surgical Intensive Care and pain medicine
Beni-Suef University