Hemodynamic Stability of Fentanyl Based Versus Lidocaine Based Induction of Anesthesia in Hypertensive Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MAP
研究概览
简要总结
Hypertension is an important health challenge that affects millions of people across the world today and is a major risk factor for multiple system comorbidities. Intraoperative hypotension may lead to negative outcomes. 'Post-induction hypotension' (PIH; i.e. arterial hypotension defined as hypotension during the first 20 min after anesthesia induction, or from anesthesia induction until the beginning of surgery) and 'early intraoperative hypotension' (eIOH; i.e. arterial hypotension occurring during the first 30 min of surgery). Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.
详细描述
Since post induction hypotension is mainly caused by anesthetic drugs, developing a technique for the induction of anesthesia that provides adequate hypnosis with stable hemodynamics during surgery is critical, especially for hypertensive patients. (4) Propofol is the most commonly used drug for anesthesia induction; however, its use is usually associated with hypotension through vasodilation and direct myocardial depression. (5) Opioid drugs are usually added to propofol to potentiate its hypnotic effect; however, they also potentiate propofol's negative hemodynamic effect at the same degree, even with low doses of propofol (5).
Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. (6) Lidocaine/ketamine combination showed a favorable hemodynamic profile following rapid-sequence induction of anesthesia in septic shock patients [14]. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
An investigator not participating in the study was responsible for drug preparation and allocation according the computer generated random numbers.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA II, Hypertensive patients with the following criteria:
- •Diagnosed with hypertension more than 5 years and on continuous medications.
- •Controlled hypertension (systolic pressure < 140 mm Hg and the diastolic < 90 mm Hg).
- •Age: 18-60 years of both sexes.
- •Elective non cardiac surgery requiring general anesthesia.
排除标准
- •Uncontrolled hypertension (SPB > 140 mm Hg) OR (DBP < 90 mm HG).
- •SVV (stroke volume variability) ≥
- •Patients with suspected difficult intubation as judged by the attending anesthetist during the preoperative assessment and patients for whom an alternative device other than an endotracheal tube will be considered.
- •History of drug abuse.
- •Obese patients (BMI ≥ 35kg/m2).
- •Allergy to any of the used medications.
研究组 & 干预措施
The lidocaine group
Anesthesia will be induced using 1.5 mg/kg lidocaine in the lidocaine group (L), 2mg/kg propofol, and 0.5 mg atracurium.
干预措施: Lidocaine IV (Drug)
The fentanyl group
Anesthesia will be induced using 2 µg/kg fentanyl in the fentanyl group (F), 2mg/kg propofol, and 0.5 mg atracurium.
干预措施: Fentanyl (Drug)
结局指标
主要结局
MAP
时间窗: 1 minute after GA induction
Mean Arterial blood pressure 1 minute after induction of anesthesia.
次要结局
- Number of hypotensive episodes(20 minutes)
研究者
Moshira sayed mohamed
lecturer
Theodor Bilharz Research Institute