the Sedative Efficacy of Preoperative Pregablin Versus Gabapentin in Elderly Undergoing Abdominopelvic Surgery : a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Intraoperative sedation levels are assessed using the Ramsay Sedation Scale .
研究概览
简要总结
Several studies have evaluated the efficacy of pregabalin in reducing preoperative anxiety, with inconsistent results. Similarly, inconclusive results have been reported regarding gabapentin and its effects in reducing preoperative anxiety. A previous study reported that a single dose of gabapentin or pregabalin administered 60 minutes before surgery in adults under general anesthesia was effective in reducing acute preoperative anxiety and elevated levels of sedation before and after surgery, with pregabalin having better anxiolytic and sedative effects than gabapentin. However, no previous studies have compared the efficacy of preoperative pregabalin or gabapentin as premedication to reduce intraoperative anxiety and induce sedation in geriatric patients undergoing major surgery with regional anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include :
- •geriatric patients, aged 65 years or older,
- •scheduled for elective abdominopelvic surgery with regional anesthesia
- •American Society of Anesthesiologists (ASA) physical status I or II.
排除标准
- •We will exclude patients with any of the following:
- •history of allergy to gabapentin or pregabalin;
- •current use of gabapentin or pregabalin for other indications
- •history of chronic pain or chronic daily use of analgesics; a
- •history of epilepsy, other neurological disorders, cognitive impairment, or severe psychiatric disorders;
- •severe cardiovascular or respiratory diseases;
- •impaired renal function; and a history of drug or alcohol abuse.
- •patients with anticipated prolonged duration of surgery for more than two hours
研究组 & 干预措施
group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg),
干预措施: One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water; (Drug)
group II patients will receive two capsules of gabapentin (Conventin) 300 mg (total = 600 mg),
干预措施: One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water; (Drug)
group III patients will receive a matching placebo in the form of two capsules of powdered multivita
干预措施: One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water; (Drug)
结局指标
主要结局
Intraoperative sedation levels are assessed using the Ramsay Sedation Scale .
时间窗: 1 hour after giving the drug
The Ramsay Sedation Score is a scale used to assess the level of sedation in patients. It ranges from 1 to 6, with higher scores indicating a deeper level of sedation score 1: Patient is anxious, agitated, or restless. Score 2: Patient is cooperative, oriented, and tranquil. Score 3: Patient responds to commands only. Score 4: Patient responds briskly to a light glabellar tap or loud auditory stimulus. Score 5: Patient responds sluggishly to a light glabellar tap or loud auditory stimulus. Score 6: Patient does not respond to pain.
次要结局
未报告次要终点
研究者
Marianne Magdy Youssef
Lecturer of anaesthesia ,icu & pain management
Cairo University