| CTRI Number |
CTRI/2025/10/095867 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oral carbohydrate drink] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Preoperative Carbohydrate Drink versus Fasting on Blood Cell Count in Breast Cancer Surgery Patients |
|
Scientific Title of Study
|
Effect of preoperative oral carbohydrate intake and conventional fasting on neutrophil-lymphocyte ratio in patients undergoing modified radical mastectomy: a randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Rohan Katare |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical college |
| Address |
Room no 302 Third Floor Department Of Anaesthesiology
Bharati Vidyapeeth (Deemed to be University) Medical College Pune
Bharati Vidyapeeth Educational Campus, Pune-Satara Road, Pune-411 043, Maharashtra, INDIA
Pune
MAHARASHTRA
411037
India |
| Phone |
9167261964 |
| Fax |
|
| Email |
katarerohan.rk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Konnur |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical college |
| Address |
Third floor, Department of Anesthesiology, Bharati Vidyapeeth deemed to be University Medical college and Hospital, Pune
Pune
MAHARASHTRA
411037
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Konnur |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical college |
| Address |
Third floor, Department of Anesthesiology, Bharati Vidyapeeth deemed to be University Medical college and Hospital, Pune
Pune
MAHARASHTRA
411037
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Medical College, Pune
Bharati Vidyapeeth Educational Campus, Pune-Satara Road, Pune-411 043, Maharashtra, INDIA |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research centre |
| Address |
Bharati Hospital and Research centre, Pune Satara road, Pune, 411043 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Rohan Katare |
Bharati Hospital and Research Centre |
Room no 302 Third Floor, Department Of Anaesthesiology
Bharati Vidyapeeth (Deemed to be University) Medical College Pune Satara road 411043 Pune Maharashtra India
Pune
MAHARASHTRA |
9167261964
katarerohan.rk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients with conventional fasting |
Will be kept overnight fasting prior to surgery as per conventional hospital protocol. |
| Intervention |
Patients with oral carbohydrate intake |
Will receive Preoperative 250ml of Oral Clear Carbohydrate Rich Drink (50gm of Maltodextrin) 2 hours prior to surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged between 18 to 60 years of age.
Patient undergoing elective modified radical mastectomy under general anaesthesia.
American Society of Anaesthesiologist (ASA) grade I, II and III patients
|
|
| ExclusionCriteria |
| Details |
BMI more than 30kg per m2
Patient with recurrent CA Breast
Patient on Chemotherapy and Immuno-modulator Therapy within 1 month of surgery
Patients with Diabetes Mellitus any other infective pathology
Patient who failed to complete the oral drinks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in neutrophil to lymphocyte ratio |
at six hours and twenty four hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in blood sugar levels |
at six hours and twenty four hours |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to compare the effect of preoperative oral carbohydrate intake and conventional fasting on the neutrophil lymphocyte ratio in patients undergoing modified radical mastectomy under general anesthesia. A total of 54 patients will be randomly divided into two groups. The study group will receive 250 milliliters of a carbohydrate rich drink containing maltodextrin two hours before surgery, while the control group will follow conventional overnight fasting. Neutrophil lymphocyte ratio and blood sugar levels will be measured preoperatively and at six and twenty four hours postoperatively. The study seeks to determine whether preoperative carbohydrate intake can attenuate the inflammatory stress response, reduce insulin resistance, and improve metabolic stability compared to prolonged fasting in patients undergoing major breast surgery. |