A study to compare the effects of two different dosages of oral melatonin 1 hour before induction for attenuation of haemodynamic response to endotracheal intubation under general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To study attenuation in stress repsonse and haemodynamics and
研究概览
简要总结
THE PURPOSE OF THIS STUDY IS TO COMPARE THE EFFECTS OF TWO
DIFFERENT DOSAGES OF ORALLY ADMINISTERED MELATONIN 60 MINUTES BEFORE INDUCTION FOR MONITORING
ATTENUATION OF HAEMODYNAMIC RESPONSE TO ENDOTRACHEAL****INTUBATION AND ALSO TO ASSESS POST OPERATIVE SEDATION SCORE 120 MINS AFTER EXTUBATION IN PATIENTS UNDER GOING ELECTIVE OPERATIVE INTERVENTIONS UNDER GENERAL ANAESTHESIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to sign informed consent.
- •Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
- •Patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia.
- •Patient having mouth opening more than 3cm Patient with Malampatti grade 1 and 2.
排除标准
- •Patients unwilling to participate in the study.
- •Patients having contraindication to endotracheal intubation/general anaesthesia.
- •Patient having mouth opening less than 3cm.
- •Patient with Mallampati grade 3 and 4 body mass index (BMI) more than 30 kg per m square.
- •patients taking anxiolytics, sedatives, antipsychotic, or antiepileptic drugs.
- •Patients having a sleep disorder, hiatus hernia, gastroesophageal reflux, known allergy to melatonin, and a known case of coronary artery disease.
- •Patients with ischemic and valvular heart disease.
结局指标
主要结局
To study attenuation in stress repsonse and haemodynamics and
时间窗: Baseline | 60 mins after drug administration | Just after induction | Just after laryngoscopy and intubation | At 1 minute | At 3 minutes | At 5 minutes | At 10 minutes | At 15 minutes
during intubation and laryngoscopy
时间窗: Baseline | 60 mins after drug administration | Just after induction | Just after laryngoscopy and intubation | At 1 minute | At 3 minutes | At 5 minutes | At 10 minutes | At 15 minutes
次要结局
- To study post op sedation score after extubation or any side effects upto 120 minutes.(Ramsey sedation scale(RSS) will be used to assess post op sedation score at 15, 30, 60, 90 and 120 minutes after extubation.)
研究者
SHAH VIHAR PAURAVBHAI
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre