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临床试验/CTRI/2025/09/094394
CTRI/2025/09/094394尚未招募不适用

The Effects of Oral Melatonin on Preoperative Anxiety,Sedation and Induction Dose of Propofol in a Tertiary Care Centre.A Randomised Placebo Control Study.

Sapthagiri Institute of Medical Sciences and Reserch Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the effect of oral Melatonin versus Placebo on induction dose of Propofol.

研究概览

简要总结

Anxiety is common in surgical patients during the preoperative period. Preoperative anxiety is described as an unpleasant state of uneasiness or tension that is secondary to a patient being concerned about a disease, hospitalization, anaesthesia and surgery, or the unknown. It may cause patients to avoid planned surgery. If anxiety is marked it causes all the signs of sympathetic stimulation and stress. High levels of preoperative anxiety have unfavourable effects on induction and maintenance of anaesthesia as well as on the recovery from anaesthesia and surgery. Anxious patients require higher doses of anaesthetic induction agents and postoperative analgesic drug. Hence the most important single reason for premedicating patients before surgery is to reduce anxiety. Reducing anxiety is an important goal in good anaesthesia management.

Melatonin (N-acetyl-5-methoxytryptamine) is a hormone naturally produced in the brain, secreted by the pineal gland, whose receptors are found throughout the central nervous system and other body tissues. It is known to be an effective hormone in sleep disorders, anxiety, and pain, as well as an anti-inflammatory antioxidant, used as a premedication.

A dose range of melatonin premedication is used to provide sedation and analgesia without cognitive impairment and psychomotor skills, and without any increase in recovery time. Several studies reported that melatonin has analgesic potential in addition to anxiolytic and sedative effects without disturbances of the cognitive and psychomotor skills and thus improves the quality of recovery.• Considering these facts, the present study is planned to assess the effects of melatonin on preoperative anxiolysis, sedation and induction dose of propofol. Its hypnotic and anesthetic sparing properties is studied by evaluating the induction dose of propofol

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1]ASA 1 & 2 2]Age 18yrs to 50 yrs of both sexes 3]Patients undergoing elective surgeries under GA 4]Informed consent.

排除标准

  • 1]Patients with difficult airway as assessed during PAC 2]Patients who have psychiatric,Neurological,Neuromuscular or Cardiovascular diseases or impairement of renal or hepatic functions.

结局指标

主要结局

To compare the effect of oral Melatonin versus Placebo on induction dose of Propofol.

时间窗: To compare the effect of oral Melatonin versus Placebo on induction dose of Propofol , vitals noted every 15minutes till induction.

次要结局

  • To compare the effect of oral Melatonin versus Placebo on preoperative anxiety, sedation in patients undergoing general anaesthesia using hemodynamic parameter, visual facial analauge score & Ramsy sedation score respectively(Hemodynamic parameters & sedation score will be noted at the time of medication & after every 15 minutes till at the time of loss of verbal response.)

研究者

发起方
Sapthagiri Institute of Medical Sciences and Reserch Center
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rajashekar Rama Poojari

Sapthagiri Institute of Medical Sciences, and Research Centre

研究点 (1)

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