Head and neck cancer patients undergoing oncosurgery- assessment of perioperative stress via Role of Sleep quality and duration of preoperative fasting.
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/04/051301
- Lead Sponsor
- not applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult patients having head and neck cancer undergoing
elective tumor resection surgery
1.Less than 18 years age.
2. patients apart from head and neck cancers.
3. Patient with pre-existing (before diagnosis of cancer) history of sleep disturbance or
hereditary sleep disturbance.
4. Patient with advance cardio-pulmonary compromise (NYHA class 4).
5. Patients with history of psychiatric illness mainly Schizophrenia or other psychosis or
neurosis.
6. Patient unable to communicate or understand the assessment tools.
7. BMI more than 30.
8. Diabetic patients and Hypertensive patients.
9. Patients receiving exogenous thyroid supplements or antithyroid medications.
10. ASA grade IlI and IV.
11. Major blood loss during surgery.
12. Missing data on study variables
13. Patients refusing informed consent
14. Patients receiving medications known to interfere with hormonal response to stress (e.g.
Beta blockers, steroids etc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. IVCCI as a determinant of intravascular volume status.(average of 3 readings) <br/ ><br>2. Sleep score as determined by the wrist sleep tracking device (average reading of 3 <br/ ><br>preoperative days). <br/ ><br>3. Serum cortisol and CRP levels (taken 8PM previous day, 8AM in the morning, 2 <br/ ><br>hours after induction of anaesthesia and 24 hours after surgery).Timepoint: serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2 <br/ ><br>hours after surgery and 24 hours after surgery
- Secondary Outcome Measures
Name Time Method Relation between sleep score (as measured by wrist sleep tracking <br/ ><br>device) and stress markers (Cortisol). <br/ ><br>Relation between in hospital sleep score and the PSQI score (sleep <br/ ><br>quality over previous one month)Timepoint: 4 weeks