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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  
NIL 
 
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  
Name  Address 
NIL   
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.
 
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