Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Surgical Stress Response Using BIS
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary end point; assessment of change in blood biochemical indicators of surgical stress
研究概览
简要总结
It is hypothesized that propofol, when used in general anesthesia (GA) influence patient's stress status and consequently affect stress response parameters. Hence, the objective of the presented research is to assess whether the propofol has anti-stress effect or not in patients undergoing surgeries that require GA and classified as The American Society of Anesthesiologists physical status 1 (ASA PS1)
详细描述
- Forty patients will be divided into two groups of patients (n=20 each), where in the first group anesthesia induction will be with propofol as a single agent, while patients in the second group will be anesthetized by propofol/fentanyl and the depth of anesthesia will be determined by BIS score and will be kept at 40-60.
- In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters:
I- Hemodynamic indicators II- Catecholamines . III- Fasting blood glucose IV- Insulin level V- Cortisol VI- Vasopressin
VII- Cytokines:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- 否
入选标准
- 未提供
排除标准
- •Patients who refused to participate in the study or to sign the consent form
- •The very young and very old patients
- •Severely agitated (panicked).
- •ASA1 patients who had bradycardia during propofol induction and was reversed with atropine.
- •Patients with any of the following pathologies: liver, kidney, lung, or cardiac diseases, allergic to medicines, alcohol abuse, pregnant, or having endocrine or neuropsychiatric diseases. Moreover, those with sepsis syndrome with hemodynamic instability, hypothermia, and poorly controlled coagulopathy will not be enrolled in this study.
研究组 & 干预措施
propofol
this arm will receive propofol in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins
干预措施: Propofol (Drug)
propofol and fentanyl
this arm will receive propofol and fentanyl in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins
干预措施: Propofol (Drug)
propofol and fentanyl
this arm will receive propofol and fentanyl in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins
干预措施: Fentanyl (Drug)
结局指标
主要结局
Primary end point; assessment of change in blood biochemical indicators of surgical stress
时间窗: blood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
blood testing includes: Catecholamines 1. Epinephrine 2. Nor epinephrine , Fasting blood glucose, Insulin level, Cortisol, Vasopressin, and Cytokines
次要结局
- Secondary end point; assessment of change in BIS number(BIS readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins)
- Tertiary end point; assessment of change in blood pressure(blood pressure readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins)
- Quaternary end point; assessment of change in heart rate(heart rate readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins)
研究者
May Mohamed Abdalla
Teaching assistant
Cairo University