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CTRI Number  CTRI/2025/08/093202 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of drink before surgery on blood glucose in diabetic patients 
Scientific Title of Study   Effect of preoperative oral carbohydrate on perioperative blood glucose in Indian patients with type 2 diabetes mellitus scheduled for surgery under general anaesthesia - a randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishal Sharma 
Designation  Post graduate student 
Affiliation  University college of medical sciences 
Address  Dept. of anaesthesiology and critical care university college of medical sciences and guru teg bahadur hospital dilshad garden , new delhi

North East
DELHI
110095
India 
Phone  9643514385  
Fax    
Email  drvishalsharma9997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  RS Rautela 
Designation  Director Professor 
Affiliation  University college of medical sciences 
Address  Department of anaesthesiology and critical care university college of medical sciences dilshad garden , new delhi

North East
DELHI
110095
India 
Phone  9868399699  
Fax    
Email  rsramb@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vishal Sharma 
Designation  post graduate student 
Affiliation  University college of medical sciences 
Address  dept. of anaesthesiology and critical care university college of medical sciences dilshad garden,new delhi

North East
DELHI
110095
India 
Phone  9643514385  
Fax    
Email  drvishalsharma9997@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences Dilshad Garden Delhi 110095 
 
Primary Sponsor  
Name  university college of medical sciences 
Address  University college of medical sciences dilshad garden new delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 
DRVISHAL SHARMA  Guru Teg Bahadur Hospital Dilshad Garden Delhi  Main ICU Second Floor OT Block Department of Anaesthesia Dilshad Garden Delhi
North East
DELHI 		 09643514383

drvishalsharma9997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Energizer drink will be given  In group A patients 296 ml of energizer drink will be given 2 h before surgery 
Intervention  Preoperative drink will be given  All patients will receive either preoperative oral carbohydrate drink or plain drinking water 2 h before the surgery 
Comparator Agent  Water will be given  In group B patients 296 ml of plain drinking water will be given 2 h before surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients older than 18 years with type II diabetes, with HbA1c less than 7 (within last month) and fasting blood glucose on the morning of surgery within 80-180 mg/dL scheduled for elective surgery under general anaesthesia will be included. 
 
ExclusionCriteria 
Details  Patients with any of the following will be excluded:
1.Known case of T1DM, Type II DM requiring insulin therapy, pheochromocytoma, carcinoid tumor etc.
2.H/o pancreatitis, alcoholism, jaundice or liver disorders
3.Obesity (BMI more than 30 kg/m2)
4.Patients with history of gastro-oesophageal reflux, gastric outlet/intestinal obstruction, emergency surgery, pregnant females
5.Patients on continuous steroid therapy for more than 5 days in the last one year.
6.Unwilling to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood Glucose level  Once, 2 hours after preoperative drink 
 
Secondary Outcome  
Outcome  TimePoints 
Perioperative glucose control   
Insulin level  T0-fasting serum insulin levels
T1-2 hours after water/carbohydrate drink
T24-24 hours after the surgery 
Insulin resistance  T0-fasting
T1-2 hours after water/carbohydrate drink
T24-24 hours after the surgery 
Post operative nausea and vomiting  0-2 hours
2-6 hours
6-24 hours 
Post-surgery recovery pattern   
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   18/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Patients undergoing elective surgery are subjected to prolonged period of fasting in view of risk of pulmonary aspiration. Preoperative fasting state leads to a catabolic state, which adds to patient discomfort and delayed mobilization. Prolonged fasting and surgical trauma enhance the release of stress hormone, which leads to the development of hyperglycemia and insulin resistance (IR). Preoperative oral carbohydrate (POC) has shown beneficial effects in postoperative patient outcome and in decreasing hyperglycemia and IR. But, the effect of POC administration in Indian patients with Type 2 diabetes mellitus (DM) still remains inconclusive. Therefore, in this study we aim to see the effect of preoperative oral carbohydrate on perioperative blood glucose in Indian patients with Type 2 DM scheduled for surgery under general anaesthesia. The study will be conducted after obtaining approval from Institutional Ethics Committee-Human Research and written and informed consent. Patient will be asked to omit oral hypoglycemic agents as routinely done before surgery. Last meal time will be  noted for all the patients. An independent anaesthesiologist not involved in the further management of the patient will administer the carbohydrate drink/water as per group allocation based on a computer generated table of random numbers. Group A: Patients in this group will remain nil per orally for solids for at least 6 hours and will receive 296 ml drinking water 2 hrs before surgery. Group B: Patients in this group will remain nil per orally for solids for at least 6 hours and will receive 296 ml of oral carbohydrate solution containing 50g maltodextrin (Energizer-Neon laboratories) 2 hours before surgery. Patients will be taken inside the operating room where routine monitoring will be initiated. General anaesthesia will be given and the surgery will be allowed to proceed. Hourly glucose measurements will be done (capillary blood glucose). Blood samples will be collected for the estimation of serum insulin for the calculation of insulin resistance. Intraoperatively insulin will be administered as per Vellore regime to maintain blood glucose <180 mg/dL.
 
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