A prospective randomized double blinded comparison of the effect of tablet Lorazepam(1mg) and tablet Alprazolam(0.5mg) administered as oral premedication 3 hours prior to general anesthesia in patients undergoing elective laparoscopic cholecystectomy.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary Objective –
研究概览
简要总结
Although anxiolytic-sedative agents are used preoperatively since the advent of anesthesia, many aspects of this treatment, including the intended effects among which anxiolysis, and optimal agents, remain unclear. High levels of preoperative fear and anxiety correlate with various unfavorable outcomes ,including increase in postoperative analgesia requirements, prolonged post anesthesia care unit or hospital stay, it can lead to essential procedures being postponed, delay postoperative recovery, and delayed negative psychological effects.
Anxiolytic medication is a common way to address preoperative anxiety. A common way to help patients cope with preoperative anxiety is to administer anxiolytic medication, most commonly benzodiazepines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient giving written consent.
- •Patients belonging to ASA grade I and II.
- •All genders
- •Normal BMI(18.5-25) subjects.
- •Patients in the age group (18-60years) undergoing elective laparoscopic cholecystectomy.
排除标准
- •Patients not giving consent.
- •ASA grade III and IV.
- •Emergency surgeries.
- •Patient who had taken analgesic, sedative, antidepressant, and on antiepileptic drugs were excluded.
- •Patients with psychiatry illness will be excluded.
- •Patients with anticipated difficult airway.
结局指标
主要结局
Primary Objective –
时间窗: At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2)
1.Comparison of Alprazolam and Lorazepam in terms of anxiolysis by Hamilton anxiety rating scale (HAM-A).
时间窗: At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2)
2. Comparison of level of amnesia by MMSE score at time T1 and T2.
时间窗: At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2)
次要结局
- Secondary objectives – (i)Comparison of level of sedation by using Ramsey sedation score at time T1 & T2(At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2))
研究者
Dr Aruna Bharti
Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh.