Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone: a Randomized, Double Blind Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in VAS Anxiety Score Relative to Baseline After Premedication
研究概览
简要总结
Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and thus paradoxically increases episodes of arousal during sleep and thus causes restlessness and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the perception of sound sleep in the perioperative period.
Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of 0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P), approximately 90 minutes before surgery.
详细描述
Review of literature:
Benzodiazepines are among the most popular drugs used for preoperative medication to produce anxiolysis, amnesia, and sedation. However, they negatively influence sleep quality by decreasing the duration of REM sleep and slow wave sleep.
Alprazolam is more anxioselective than the more commonly used ones like midazolam, lorazepam and diazepam.Melatonin (N-acetyl-5-methoxytryptamine) is an emerging premedicant as it possesses anxiolytic and sedative properties without impairing cognitive or psychomotor skills.5 Moreover, it has an excellent safety profile.
We designed this prospective randomized double blind placebo controlled study to assess whether addition of melatonin to alprazolam has any benefit over alprazolam, melatonin or placebo alone as a premedication agent.
Rationale of the study Melatonin facilitates sleep onset and improves the quality of sleep. On the other hand, benzodiazepines suppress endogenous melatonin levels and thus paradoxically increase episodes of arousal during sleep causing restlessness and hang over effects (fatigue).
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •(ASA 1&2),
- •aging 18 to 65 years
- •having anxiety VAS score of more than 2
- •posted for general anaesthesia with estimated duration of < 3 hours.
排除标准
- •patients taking analgesics, sedatives, antiepileptics or antidepressants,
- •suffering from obesity (BMI ≥ 28) or neuropsychiatric disease,
- •having allergy to the study drugs
研究组 & 干预措施
Melatonin
Premedication with 3 mg melatonin (Meloset) tablet orally 1-2 hour prior to anesthesia
干预措施: meloset (melatonin) (Drug)
melatonin and alprazolam premedication
Premedication with 3 mg melatonin and 0.5 mg alprazolam (Stresnil) tablet orally 1-2 hrs prior to anesthesia
干预措施: stresnil ( melatonin and alprazolam) (Drug)
alprazolam premedication
Premedication with 0.5 mg alprazolam (Alprax) tablet orally 1-2 hr prior to anesthesia
干预措施: (alprax) alprazolam (Drug)
placebo premedication
Premedication with a similar looking placebo tablet orally 1-2 hr prior to anesthesia
干预措施: placebo (Drug)
结局指标
主要结局
Change in VAS Anxiety Score Relative to Baseline After Premedication
时间窗: Change from baseline in VAS anxiety score at 15 minutes after premedication
VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication
时间窗: Changes from baseline in VAS anxiety score at 30 minutes after premedication
VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication
时间窗: Changes from baseline in VAS anxiety score at one hour after premedication
VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
次要结局
- Sedation Score at One Hour After Premedication(Sedation score at 1 hour after the premedication)
- Orientation Score(Orientation score at one hour after premedication)
- Number of Patients With Intact Memory(24 hour after surgery)
- Amount of Propofol Consumption(1 - 2 hour after premedication)
- Number of Patients With Loss of Memory for Being Transferred to Operating Room.(24 hour after surgery)
研究者
Krishna Pokharel
Associate Professor
B.P. Koirala Institute of Health Sciences