| CTRI Number |
CTRI/2026/03/105201 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of drinking a carbohydrate-rich drink before surgery on blood sugar levels and recovery in patients undergoing major surgery |
|
Scientific Title of Study
|
A randomized controlled study of pre operative oral carbohydrate loading versus fasting in patients undergoing major surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeraja Nair |
| Designation |
Junior resident |
| Affiliation |
Dr D. Y. Patil Medical college, Hospital and research centre |
| Address |
Department of Anesthesia , fifth floor, Hitech building, Dr.D.Y.,Patil medical College, Hospital, and research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7022886549 |
| Fax |
|
| Email |
neerajanair17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
HOD and professor, Department of anaesthesiology |
| Affiliation |
Dr D Y Patil Medical College, Hospital and Research Centre |
| Address |
Dr Chhaya Suryawanshi , Department of Anesthesia , Dr.D.Y.Patil medical College, Hospital, and research Centre, sant Tukaram nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
HOD and professor, Department of anaesthesiology |
| Affiliation |
Dr D.Y. Patil Medical College Hospital and Research centre |
| Address |
Department of Anesthesia , fifth floor, Hitech building, Dr.D.Y.,Patil medical College, Hospital, and research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, fifth floor, Hitech, building, Dr. D.Y. Patil medical College, Hospital and research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India, pin code-411018. |
|
|
Primary Sponsor
|
| Name |
Neeraja Nair |
| Address |
Department of Anesthesia , fifth floor, Hitech building, Dr.D.Y.,Patil medical College, Hospital, and research Centre, Pimpri, Pune
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Neeraja nair |
Dr. D.Y. Patil medical College Hospital and research Centre |
Department of Anesthesiology Dr.D.Y.,Patil medical College, Hospital, and research Centre, Pimpri, Pune
Pune
MAHARASHTRA |
7022886549
neerajanair17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehics Sub -Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral carbohydrate loading |
Administration of 250 ml of clear carbohydrate-rich oral drink given orally once, 2 hours before induction of anaesthesia.
The intervention duration is limited to the pre-operative period only and is completed prior to surgery. |
| Comparator Agent |
Standard pre operative findings |
Patient will follow routine pre operative fasting guidelines as per institutional and anaesthetic protocol without administeration of oral carbohydrate drink |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 and grade 2
Patient posted for elective major surgeries
Hemodynamically stable patient with all routine investigations within normal limits
Written consent from the concerned patients |
|
| ExclusionCriteria |
| Details |
Patient who are not willing to participate in the study
Patient with ASA grade 3 and above physical status
Patients who are aged more than 60 years and less than 18 years of age
Patient with known-allergy to the study of carbohydrate drink
Patient who are posted for emergency procedures
Pregnant woman
Patient with delete gastric emptying or gastric Paris is
Patient with psychiatric, endocrine disorders, impaired hepatic or renal function |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare preoperativeboral carbohydrate loading versus fasting in patients undergoing major surgeries
to compare pre operative carbohydrate loading versus fasting in patient undergoing major surgeries
|
To assess pre-operative intraoperative and post-operative blood Loukos levels and haemodynamic changes in both groups at five minutes, 10 minutes, 15 minutes, 30 minutes, at the end of the surgery and 10 minutes after surgery
to compare pre operative carbohydrate loading versus fasting in patient undergoing major surgeries
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare preoperativeboral carbohydrate loading versus fasting in patients undergoing major surgeries
to compare pre operative carbohydrate loading versus fasting in patient undergoing major surgeries
|
To assess hunger, thirst and anxiety and to compare post-operative nausea and vomiting and evaluate post-operative return of gastric function time in both study groups. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/03/2026 |
| 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="1"
Months="6"
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
|
It is a randomised controlled study of pre-operative oral carbohydrate loading versus fasting in patients undergoing major surgeries. Para metres that will be compare preoperative, intraoperative and post-operative blood glucose levels and to assess haemodynamic changes in both study groups and to assess patient comfort, pre-operatively and post operatively, including hunger, thirst and anxiety and to compare post-operative nausea and vomiting in both study groups and to evaluate post-operative return of gastric function time in both study groups |