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临床试验/CTRI/2025/08/092374
CTRI/2025/08/092374尚未招募2 期

Effect of music therapy on hemodynamic response to endotracheal intubation in patients undergoing elective surgery under general anaesthesia: A randomized controlled study

Maulana Azad Medical College and associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
Mean change in heart rate to intubation in patients undergoing elective surgery under general anaesthesia

研究概览

简要总结

In this research there will be 2 groups, one in which we will apply headphones and play Raga Hamsadhwan, which is an instrumental flute, will be group M, and another group, C, in which we will apply only ambient noise-cancelling headphones.

Baseline anxiety A0 and hemodynamic parameters, heart rate, blood pressure, and oxygen saturation T0 will be measured.

After 10 minutes of music therapy, we will again assess the anxiety level A1 and hemodynamic parameters, heart rate, blood pressure and oxygen saturation T1

We will shift the patient to the operating theatre with headphones on and induce the patient with standard general anaesthesia using propofol, fentanyl and vecuronium.

We will intubate the patient with direct laryngoscopy and measure the hemodynamic parameters immediately and at 2-minute intervals for 10 minutes for stress response to intubation and every 5 minutes thereafter.

Maintain the depth of anaesthesia with isofluran,e oxyge, nitrous oxide, and an intraoperative bolus of fentanyl and vecuronium, and maintain a BIS of 40-60

Then we will extubate the patient post-surgery after achieving a TOF ratio of 0.9 and adequate signs of neuromuscular monitoring

We will stop the music which was playing intraoperatively only after extubation

We will also take blood samples for S. cortisol at baseline pre-operative, 2 min post-intubation and 4 hours post-intubation to compare levels of stress response along with anxiety and hemodynamic parameters

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 American Society of Anesthesiologists Physical Status ASA I and II 2 Expected duration of elective surgery less than 2 hours.

排除标准

  • 1 Patient with hearing impairment 2 Diagnosed psychiatric or neurological illness 3 Hypertensive patients on beta blocker 4 Known case of heart disease 5 Mallampati class III and IV.

结局指标

主要结局

Mean change in heart rate to intubation in patients undergoing elective surgery under general anaesthesia

时间窗: 2, 4, 6, 8, 10 minutes post intubation

次要结局

  • 1. Mean change in mean arterial pressure to intubation as a effect of music therapy(2. Mean preoperative anxiety as assessed by Amsterdam preoperative anxiety & information scale (APAIS))

研究者

发起方
Maulana Azad Medical College and associated Lok Nayak Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mukul Kumar

Maulana Azad Medical College

研究点 (1)

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