跳至主要内容
临床试验/CTRI/2025/12/099481
CTRI/2025/12/099481尚未招募不适用

The effects of Oral Melatonin on pre operative Anxiety,Sedation and Induction dose of Thiopentone Sodium in a Tertiary Care Centre - A Randomised Placebo control study

Sapthagiri institute of medical sciences and research center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月29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

研究概览

简要总结

During the preoperative period anxiety is commonly seen in patients posted for surgery. An unpleasant state of tension or an uneasy feeling because of patients concern regarding the disease, hospital admission, anesthesia and surgery is described as preoperative-anxiety.It can lead to sympathetic stimulation and in some cases may lead to patient deferring surgery. may cause patients to avoid planned surgery.High levels of preoperative anxiety can have unfavorable effects on induction as well as maintenance of anaesthesia and lead to a delayed recovery from anaesthesia due to higher doses of induction agents and post operative analgesic drugs. An important goal in optimal anaesthetic management is to reduce the anxiety and this can be accomplished by good premedication. Preoperative anxiety can be reduced with certain pharmacological interventions. Benzodiazepines like midazolam is commonly used as a premedication to decrease the levels of anxiety. It has disadvantages like paradoxical reactions, variable bioavalibity, can interact with opioids and lead to a delay in discharge from the post anaesthesia care unit. A naturally occurring neurohormone Melatonin(N-acetyl-5 methoxy tryptamine) is secreted in the human body by the pineal gland. Studies have shown that decrease in pre operative anxiety and sedation can be caused by melatonin without impairing orientation ,psychomotor skills and cognition which in turn improve the quality of recovery. It is a novel hypnotic with anaesthetic sparing effect and a wide safety margin in children a dose of 0.4 mg/kg has been used safely. As a result we designed this study to evaluate the effects of premedication with melatonin on preoperative anxiety and sedation. 2 Considering these facts, the present study is planned to assess the effects of melatonin on preoperative anxiolysis, sedation and induction dose of Thiopentone sodium.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA 1 and 2 2) Patients undergoing elective surgeries under GA 3) Informed consent.

排除标准

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

研究者

发起方
Sapthagiri institute of medical sciences and research 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 center

研究点 (1)

Loading locations...

相似试验