Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare propofol consumption among both groups.
研究概览
简要总结
investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.
详细描述
A number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time
The effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before.
The present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization will be done via computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of series will be unknown to the investigators and the group assignment will be kept in a set of concealed envelopes each bearing only the case number on the outside. Prior to the start of the study, the appropriately numbered envelopes will be opened by the nurse, the card will determine the assigned intervention for each patient, which will be prepared by a clinical pharmacist with no other role in the study
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 -65 years
- •ASA grade I to II
- •Both sexes
- •Patients with unilateral chronic subdural hematoma
- •Patients who are vitally stable
- •Glascow coma scale 14-15
排除标准
- •Age below 50 and above 65 years.
- •Gastro intestinal tract impractabililty.
- •Patients with any substance abuse.
- •Patients with hepatic or renal insufficiency.
- •Patients on antipsychotic, anticonvulsant or anti-parkinsonian medication.
- •Vitally unstable patients who cannot tolerate propofol sedation.
- •Patients with known allergies to any of the drugs used.
研究组 & 干预措施
Placebo (Group P)
Group P: 20 patients will receive a placebo tablet preoperatively.
干预措施: Placebo (Group P) (Drug)
Melatonin (Group M)
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
干预措施: Melatonin (Group M) (Drug)
结局指标
主要结局
To compare propofol consumption among both groups.
时间窗: 24 hours Postoperative
propofol consumption per mg among both groups.
次要结局
- Number of intraoperative patients movements.(24 hours Postoperative)
- Time to first rescue analgesic in both groups.(24 hours Postoperative)
- VAS score for pain in each group(24 hours Postoperative)
- Vital Signs(24 hours Postoperative)
- Anesthesia recovery times /Hour in both groups.(24 hours Postoperative)
研究者
Ahmed Abdalla
Assistant Professor of Anesthesia
Cairo University