Pretreatment with 6% Hydroxyethyl starch for reduction of propofol injection pain : A prospective randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The preadmininstration of 100 ml of 6% Hydroxyethyl starch 3 to 5 mins before Propofol injection can significantly decrease the incidence of pain on injection with propofol in comparison to normal saline ( 28% VS 53% )
研究概览
简要总结
The study ’ Pretreatment with 6% Hydroxyethyl starch for reduction of Propofol injection pain : A prospective randomized controlled study ’ will be done at Gajra Raja Medical College , Gwalior , MP on sample size of 120 patients for the time period of 8 months . After fulfilling the eligibility criteria , patients will be randomized in two groups by closed envelope method. Group I will be receiving 100 ml 6% Hydroxyethyl starch 3-5 mins before Propofol injection , Group II will be receiving 100 ml NS 3-5 mins before Propofol injection . Pain on Propofol injection will be assessed every 10 secs by using a 0-3 Verbal Rating Score before the loss of verbal contact. Propofol induction dose , time of loss of verbal response, incidence and severity propofol injection pain in both groups , Haemodynamic parameters such as Heart rate , Systolic blood pressure , Diastolic blood pressure will be observed in both groups. After the study , results will be obtained. Primary aim of this study is to study the effect of 6% Hydroxyethyl starch pretreatment for reduction of pain on propofol injection . This study expects that pre administration of 100 ml of 6% Hydroxyethyl starch 3-5 mins before propofol injection can significantly decrease the pain on injection with propofol in comparison to Normal Saline.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients of ASA status I and II
- •Age between 18-65 years old , of either gender
- •Patientd undergoing elective surgery under general anesthesia.
排除标准
- •Emergency surgeries
- •Known history of allergy to Propofol or 6% Hydroxyethyl starch
- •Hypertensive , diabetes , presence of left ventricular dysfunction, elevated serum creatinine
- •Those in whom hand or forearm veins are not accessible.
结局指标
主要结局
The preadmininstration of 100 ml of 6% Hydroxyethyl starch 3 to 5 mins before Propofol injection can significantly decrease the incidence of pain on injection with propofol in comparison to normal saline ( 28% VS 53% )
时间窗: The pain on propofol injection will be assessed every 10 seconds before the loss of verbal contact by using a 0-3 Verbal Rating Score
次要结局
- There is no significant haemodynamic changes ( Heart rate, SBP, DBP) in both groups(The haemodynamic parameters will be assessed baseline , before induction and 5 mins after intubation.)
研究者
Dr Chongtham Pushpa Chanu
Gajra Raja Medical College , Gwalior , Madhya Pradesh