Effect of Preoperative Melatonin in Inhaled Anesthetic Consumption
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60
研究概览
简要总结
Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many functions in the body but it is mostly known for maintaining a circadian rhythm that is governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei in the hypothalamus. Melatonin works by attaching to receptors or nerve endings in the suprachiasmatic nucleus (SCN) in the hypothalamus. It binds to melatonin receptor 1 and melatonin receptor 2, commonly referred to as MT1 and MT2. People can take it as a natural or synthetic supplement to promote restful sleep. Melatonin showed promise for preventing shifts in sleep and wake times in people with jetlag and improving sleep in people with insomnia. It can also be used for headaches, cancer, and Alzheimer's disease.
Melatonin can be used as an analgesic, sedative, and hypnotic drug that can distinguish it as an attractive alternative premedicant
详细描述
A study that was done before in J Anaesth by Borazan H et al revealed that postoperative pain score in patients undergoing radical prostatectomy who received melatonin one hour before surgery as a premedication was significantly lower than the control group with a significant P-value( less than 0.05).
The entropy is indicated for adult and pediatric patients older than 2 years intraoperatively for monitoring the electric state of the brain. In adult patients, state entropy and response entropy can be used as an aid in monitoring the effects of certain anaesthetic agents which will help the user to titrate the anaesthetic agent according to the individual needs of each patient.
Furthermore, the use of entropy parameters may be associated with a reduction of anaesthetic use and faster emergence of anaesthesia. The entropy measurement is to be used as an adjunct to other physiological parameters.
To the best of investigators knowledge, there is no study that examined the effect of melatonin on inhaled isoflurane requirements intraoperatively. So, in this study, the effect of melatonin will be assessed on intraoperative inhaled isoflurane requirements in patients undergoing open nephrectomy under general anaesthesia by using entropy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be allocated to the study groups using a computer-generated random list, and the group assignments will be sealed in sequentially numbered opaque envelopes that will be opened before induction of anesthesia. The data collector will be blinded to the group assignment and to the monitoring anesthetist, and the person who will give the drug will not bethe data collector.
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 undergoing nephrectomy under general anesthesia aged from 20 to 60 years.
- •BMI 25 to 30
排除标准
- •Patients with uncontrolled hypertension.
- •Patients presenting with (IHD, significant arrhythmias, heart failure).
- •Allergy to melatonin.
- •History of epileptic seizures, psychoactive medications, neurological disorders or trauma.
研究组 & 干预措施
melatonin group
Melatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg
干预措施: Melatonin 5 mg (Drug)
control group
15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C)
干预措施: Sugar Coated Tablets (Drug)
结局指标
主要结局
Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60
时间窗: 2 hours
Inhaled Isoflurane requirement (volume %) will be titrated to maintain state entropy (SE) and response entropy (RE) readings 40-60 measured using GE carestation 650-crescent pulse anaesthesia machine(6).
次要结局
- Total intraoperative fentanyl consumption(2 hours)
- Total morphine consumption over 24 hours postoperative(24 hours)
研究者
Amany Hassan Saleh
Associate professor of anesthesia, surgical intensive care and pain management, Cairo University
Cairo University