| CTRI Number |
CTRI/2023/04/051301 [Registered on: 05/04/2023] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [RANDOMIZED PROSPECTIVE OBSERVATIONAL STUDY] |
| Study Design |
Other |
|
Public Title of Study
|
Head and neck cancer patients undergoing oncosurgery- assessment of perioperative stress via Role of Sleep quality and duration of preoperative fasting. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Gupta |
| Designation |
Academic senior resident |
| Affiliation |
AIIMS, Bhopal |
| Address |
Department of Anesthesiology, Third floor, Trauma building, All India Institute of Medical Sciences, bhopal, saket nagar
A-36, emerald park city, bagh sevaniya, Bhopal.
pin- 462043
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8889588282 |
| Fax |
|
| Email |
missekta980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuj Jain |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Bhopal |
| Address |
Department of Anesthesiology, Third floor, Trauma building, All India Institute of Medical Sciences, saket nagar,bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8435899317 |
| Fax |
|
| Email |
anuj.jain.mln@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ekta Gupta |
| Designation |
Academic senior resident |
| Affiliation |
AIIMS, Bhopal |
| Address |
Department of Anesthesiology, Third floor, Trauma building, All India Institute of Medical Sciences, saket nagar,bhopal
72,K, near manoj datta home, gali no. 1,Durga Nagar, VIDISHA
(M.P.)
464001
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8889588282 |
| Fax |
|
| Email |
missekta980@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| EKTA GUPTA |
Modular OT complex, second floor, AIIMS BHOPAL |
AIIMS, SAKET NAGAR, BHOPAL (M.P.) 462020
Bhopal
MADHYA PRADESH |
8889588282
missekta980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sleep analysis and stress biomarkers measurement preopeatively and post operatively |
sleep analysis and duration of preoperative fasting in assessing stress via stress biomarkers (serum cortisol and CRP) preoperative and postoperative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients having head and neck cancer undergoing
elective tumor resection surgery |
|
| ExclusionCriteria |
| Details |
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) |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. IVCCI as a determinant of intravascular volume status.(average of 3 readings)
2. Sleep score as determined by the wrist sleep tracking device (average reading of 3
preoperative days).
3. Serum cortisol and CRP levels (taken 8PM previous day, 8AM in the morning, 2
hours after induction of anaesthesia and 24 hours after surgery). |
serum stress biomarkers taken 8PM previous day, 8AM in the morning, 2
hours after surgery and 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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) |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
08/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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: 1. 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)
|