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Role of sleep quality and duration of fasting in determining perioperative stress in patients who have undergone chemotherapy for breast cancer prior to surgery- A prospective observational single blind study

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 - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104755
Enrollment
96
Registered
2026-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Nil: Nil

Sponsors

All India Institute of Medical Sciences Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 30 years and less than 65 years. 2. ASAI/II patients. 3. Patients undergoing elective breast cancer surgery following neoadjuvant chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Less than 30 years age. 2. Male breast cancer patients. 3. Patients apart from breast cancers. 4. Patient with pre-existing (before diagnosis of cancer) history of sleep disturbance or hereditary sleep disturbance. 5. Patient with advance cardio-pulmonary compromise (NYHA class 4). 6. Patients with history of psychiatric illness mainly Schizophrenia or other psychosis or neurosis. 7. Patient unable to communicate or understand the assessment tools. 8. BMI more than 30. 9. Uncontrolled diabetic and hypertensive patients. 10. Patients receiving exogenous thyroid supplements or antithyroid medications. 11. ASA grade III and IV. 12. Major blood loss during surgery- more than maximum allowable blood loss (MABL) i.e.65 ml/kg of ideal body weight. 13. Missing data on study variables. 14. Patients refusing informed consent. 15. Patients receiving medications known to interfere with hormonal response to stress (e.g. Beta blockers, steroids etc).

Design outcomes

Primary

MeasureTime frame
Measurement of Serum Cortisol, CRP and RBS.Timepoint: 8PM previous day 8 AM in the morning 2 hours after induction of anesthesia 24 hours post surgery.

Secondary

MeasureTime frame
IVCCI as a determinant of intravascular volume status.Timepoint: 8AM in the morning.;Sleep score of the patientTimepoint: Average reading of 3 preoperative days.

Countries

India

Contacts

Public ContactDr Anuj Jain

All India Institute of Medical Sciences Bhopal

Anuj.Jain.MLN@gmail.com9755702644

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026