The Effect of Preoperative Aminophylline on the Recovery Profile After Major Pelvi-abdominal Surgeries: Randomized Controlled Double Blinded Study
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- times to lose consciousness( LOC)
研究概览
简要总结
Several clinical studies and case reports suggested that aminophylline antagonizes the effects of diazepam , barbiturates , sevoflurane ,morphineand propofol.However, the available results from uncontrolled clinical settings make it difficult to quantify the specific effects of aminophylline on hypnotics and anesthetics
详细描述
Aminophylline, a theophylline derivative, exerts multiple pharmacological effects, either through phosphodiesterase inhibition (i.e., a potent bronchodilating action, which is often used for the treatment of bronchial asthma) or via adenosine receptor blockade .It is generally considered that the majority of actions ascribed to therapeutic doses of xanthines (caffeine and theophylline) are due to their action as adenosine receptor antagonists.
To the best of the investigator's knowledge this hypothesis was not reported in patients scheduled for major pelvi-abdominal surgeries under general anesthesia , and aminophylline was not given as premedication to test this hypothesis as it was previously administrated after the end of surgery ,also it was recommended by previous clinical studies to evaluate the effective dose of aminophylline that affect the extubation and recovery time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age: 20-60 years
- •Males and females patients
- •American Society Of Anesthesiology (ASA) physical status I- II .
排除标准
- •Patient refusal to participate in this study
- •Patient with known sensitivity to aminophylline
- •Patients with history of cardiac failure
- •Patients with renal or hepatic dysfunction and in chronic alcoholism since clearance of aminophylline is decreased.
- •Patients with peptic ulcer, hyperthyroidism, glaucoma,as these conditions may be exacerbated.
- •Patients with opioid addiction
- •Current treatment with B agonists, anticholinergic agents, tranquilizers, anticonvulsants ,or antidepressants.
- •Pregnancy.
- •Habitual coffee consumption exceeding 2 cups per day.
研究组 & 干预措施
the control group
the control group (n =15 ) the patients will receive 20 ml of normal saline IV ,20 minutes before induction of general anesthesia .
干预措施: Aminophylline (Drug)
Amiophylline (2mg)
Aminophylline 2mg:(n = 15) the patients will receive 2 mg/kg intravenous (IV) aminophylline diluted in 20 ml normal saline 20 minutes before induction of general anesthesia
干预措施: Aminophylline (Drug)
Aminophylline(4mg)
Aminophylline 4mg: (n = 15) the patients will receive 4 mg/kg intravenous (IV) aminophylline diluted in 20 ml normal saline 20 minutes before induction of general anesthesia .The study drugs will be given by an anesthetist unaware of the study protocol.
干预措施: Aminophylline (Drug)
结局指标
主要结局
times to lose consciousness( LOC)
时间窗: from the first second after administration of the anesthetic drugs and for 1-5 minutes
Times to lose of consciousness( LOC) which is defined as an OAA/S score 2 (loss of responsiveness to light tapping on shoulderor mild shaking with voice command to open eyes)
次要结局
未报告次要终点
研究者
Samaa Rashwan
Assistant professor of Anesthesiology
Beni-Suef University