| CTRI Number |
CTRI/2025/12/098522 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Drinking a Carbohydrate Drink vs.Fasting Before ENT Surgery |
|
Scientific Title of Study
|
A Prospective Randomized Controlled Clinical Study on the Effect of Oral Maltodextrin
Administration Versus Conventional Fasting in the Preoperative Period Among Patients Undergoing ENT Surgeries Under General Anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashikumar D Mainale |
| Designation |
PG Resident |
| Affiliation |
padmashree d y patil school of medicine navi mumbai |
| Address |
A- block department of anaesthesia D Y Patil school of medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra Thane Thane MAHARASHTRA 400706 India |
| Phone |
9972334347 |
| Fax |
|
| Email |
shashimainale3297@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrMona Jadhav |
| Designation |
Professor |
| Affiliation |
padmashree d y patil school of medicine navi mumbai |
| Address |
A- block department of anaesthesia D Y Patil school of medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
Thane MAHARASHTRA 400706 India |
| Phone |
9763847148 |
| Fax |
|
| Email |
monajadhav601@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrMona Jadhav |
| Designation |
Professor |
| Affiliation |
padmashree d y patil school of medicine navi mumbai |
| Address |
A- block department of anaesthesia D Y Patil school of medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
MAHARASHTRA 400706 India |
| Phone |
9763847148 |
| Fax |
|
| Email |
monajadhav601@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai |
| Address |
A- block department of anaesthesia D Y Patil school of medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shashikumar D Mainale |
D.Y Patil School Of Medicine |
A- block department of anaesthesia D Y Patil school of medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
Thane
A- block department of anaesthesia D Y Patil school of medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
Thane Mumbai MAHARASHTRA |
9972334347
shashimainale3297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethic committee for biomedical and health research of Dr DY Patil medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients 18-65 years (either of sex)
ASA grade I, II
Patients willing to comply with standard preoperative fasting and oral carbohydrate loading protocols. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients 18-65 years (either of sex)
ASA grade I, II
Patients willing to comply with standard preoperative fasting and oral carbohydrate loading protocols.
All patient undergoing elective ENT surgery under general anaesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of preoperative oral maltodextrin loading with conventional fasting on changes in haemodynamic parameters during the intraoperative period |
To compare the effect of preoperative oral maltodextrin loading with conventional fasting on changes in haemodynamic parameters during the intraoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess patient’s hunger level thirst & satisfaction just prior to induction. |
To assess patient’s hunger level thirst & satisfaction just prior to induction. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
31/12/2025 |
| 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
|
Prolonged preoperative fasting can lead to catabolic metabolism, muscle breakdown, insulin resistance, hyperglycemia, discomfort, and increased metabolic stress. Preoperative carbohydrate (CHO) loading, especially with maltodextrin, counters these effects by improving insulin sensitivity, reducing stress response, stabilizing hemodynamics, and increasing patient comfort. Aim— To evaluate the effect of preoperative oral maltodextrin loading on hemodynamic stability in patients undergoing general anaesthesia.
Primary Objective--Compare hemodynamic changes (HR, BP, MAP) between maltodextrin-loaded patients and conventionally fasted patients. Secondary Objective--Assess hunger, thirst, and overall satisfaction before induction.
All eligible patients will be screened for inclusion and informed consent was obtained. Participants were then randomly allocated into Group A or Group B. Preoperative hunger, thirst, and satisfaction scores were recorded for all patients. In the operating room, standard ASA monitoring was applied, and a uniform general anaesthesia technique was used, consisting of glycopyrrolate, midazolam, and fentanyl followed by induction with propofol and muscle relaxation with atracurium. Anaesthesia was maintained using sevoflurane. Hemodynamic parameters were monitored at baseline, after induction, every 2 minutes for the first 10 minutes, every 5 minutes until 30 minutes, and subsequently every 15 minutes until the end of surgery. At the conclusion of the procedure, standard reversal of neuromuscular blockade was administered. |