CTRI/2026/02/104755
Not yet recruiting
Not Applicable
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
All India Institute of Medical Sciences Bhopal1 site in 1 country96 target enrollmentStarted: March 9, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Measurement of Serum Cortisol, CRP and RBS.
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Age more than 30 years and less than 65 years.
- •ASAI/II patients.
- •Patients undergoing elective breast cancer surgery following neoadjuvant chemotherapy.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Measurement of Serum Cortisol, CRP and RBS.
Time Frame: 8PM previous day | 8 AM in the morning | 2 hours after induction of anesthesia | 24 hours post surgery.
Secondary Outcomes
- IVCCI as a determinant of intravascular volume status.(8AM in the morning.)
- Sleep score of the patient(Average reading of 3 preoperative days.)
Investigators
Dr Raghav Singh Jaswal
All India Institute of Medical Sciences Bhopal
Study Sites (1)
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