CTRI/2026/02/104755尚未招募不适用
Role of sleep quality and duration of preoperative fasting in determining perioperative stress in breast cancer patients undergoing elective onco-surgery after neoadjuvant chemotherapy- A prospective observational single blind study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Measurement of Serum Cortisol, CRP and RBS.
研究概览
简要总结
In this study we will be investigating associations between psychoneurological parameters (sleep quality), cortisol, and inflammatory markers altogether in breast cancer patients undergoing elective tumor resection surgery post neoadjuvant chemotherapy. This will help in understanding the role of sleep quality and duration of preoperative fasting in determining perioperative stress response in breast cancer patients undergoing tumor resection surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age more than 30 years and less than 65 years.
- •ASAI/II patients.
- •Patients undergoing elective breast cancer surgery following neoadjuvant chemotherapy.
排除标准
- •Less than 30 years age.
- •Male breast cancer patients.
- •Patients apart from breast cancers.
- •Patient with pre-existing (before diagnosis of cancer) history of sleep disturbance or hereditary sleep disturbance.
- •Patient with advance cardio-pulmonary compromise (NYHA class 4).
- •Patients with history of psychiatric illness mainly Schizophrenia or other psychosis or neurosis.
- •Patient unable to communicate or understand the assessment tools.
- •BMI more than
- •Uncontrolled diabetic and hypertensive patients.
- •Patients receiving exogenous thyroid supplements or antithyroid medications.
- •ASA grade III and IV.
- •Major blood loss during surgery- more than maximum allowable blood loss (MABL) i.e.65 ml/kg of ideal body weight.
- •Missing data on study variables.
结局指标
主要结局
Measurement of Serum Cortisol, CRP and RBS.
时间窗: 8PM previous day | 8 AM in the morning | 2 hours after induction of anesthesia | 24 hours post surgery.
次要结局
- IVCCI as a determinant of intravascular volume status.(8AM in the morning.)
- Sleep score of the patient(Average reading of 3 preoperative days.)
研究者
Dr Raghav Singh Jaswal
All India Institute of Medical Sciences Bhopal
研究点 (1)
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