Role of Sleep quality and duration of preoperative fasting in determining perioperative stress in head and neck cancer patients undergoing elective onco-surgery in Indian population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- 1. IVCCI as a determinant of intravascular volume status.(average of 3 readings)
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 newly diagnosed HNC patients
undergoing elective tumor resection surgery. This will help in understanding the role of sleep quality and duration of pre-operative fasting in determining perioperative stress response
in head and neck cancer patients undergoing tumor resection surgery.
Primary objective:
- Relation between IVCCI (as a measure of intravascular volume depletion) and stress marker levels (Serum cortisol).
Secondary Objective:
. Relation between sleep score (as measured by wrist sleep tracking device) and stress markers (Cortisol).
Relation between in hospital sleep score and the PSQI score (sleep quality over previous one month)
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Investigator 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
- •Adult patients having head and neck cancer undergoing elective tumor resection surgery.
排除标准
- •1.Less than 18 years age.
- •patients apart from head and neck 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
- •Diabetic patients and Hypertensive patients.
- •Patients receiving exogenous thyroid supplements or antithyroid medications.
- •ASA grade IlI and IV.
- •Major blood loss during surgery.
- •Missing data on study variables
- •Patients refusing informed consent 14.
结局指标
主要结局
1. IVCCI as a determinant of intravascular volume status.(average of 3 readings)
时间窗: serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2 | hours after surgery and 24 hours after surgery
2. Sleep score as determined by the wrist sleep tracking device (average reading of 3
时间窗: serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2 | hours after surgery and 24 hours after surgery
preoperative days).
时间窗: serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2 | hours after surgery and 24 hours after surgery
hours after induction of anaesthesia and 24 hours after surgery).
时间窗: serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2 | hours after surgery and 24 hours after surgery
3. Serum cortisol and CRP levels (taken 8PM previous day, 8AM in the morning, 2
时间窗: serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2 | hours after surgery and 24 hours after surgery
次要结局
- Relation between sleep score (as measured by wrist sleep tracking(device) and stress markers (Cortisol).)