Effect of Noise Cancellation on Post Operative Analgesic Requirement in patients undergoing Open Heart Surgery- A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To Compare Post operative opioid consumption during the first 24 hours after surgery
研究概览
简要总结
Moderate to severe pain is experienced by the patient under going midline sternotomy. Poorly controlled pain is associated with sympathetic nervous system activation and increased hormonal response to stress. All these lead to postoperative adverse events, including MI, cardiac arrhythmias, hypercoagulability, PPC.
Currently, systemic opioids and NSAIDs are the commonly used practices for postoperative pain management after cardiac surgery. Recently, the focus has increasingly been on non-pharmacological and non-invasive modalities of analgesia (acupuncture, educational videos music, white noise )
Correlation has been found between intraoperative noise levels and postoperative pain in clinical settings.
Research Question- Does Noise isolation decrease opioid requirements in patients undergoing cardiac surgery
Hypothesis- Noise isolation decreased postoperative pain and opioid requirements in patients undergoing cardiac surgery under general anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 70 years belonging to ASA II or III and posted for elective Cardiac Surgery with midline sternotomy.
排除标准
- •Patients who refuse to participate in the study Emergency surgery Patients who received any kind of regional block for postoperative pain Patients with cognitive deficits making them inefficient to use IV PCA pump Patient with LVEF less than forty percent Preoperative cardiac support (IV inotropes or vasoconstrictors) Morbid obesity Patients with liver and renal dysfunction Patients of opium addict.
结局指标
主要结局
To Compare Post operative opioid consumption during the first 24 hours after surgery
时间窗: 24 hours after surgery
次要结局
- 1. To compare postoperative Visual Analog Scale (VAS) pain score at rest and on cough during the first 24 hours (2, 6, 12, 18 and 24 h in intensive care unit)(2. To compare the time to extubation in both the groups)
研究者
Dr Rakesh
All India Institute Of Medical Sciences Jodhpur