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CTRI Number  CTRI/2026/03/105127 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
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   Carbohydrate Drink  
Scientific Title of Study   PREOPERATIVE ORAL CARBOHYDRATE LOADING TO ASSESS INTRAOPERATIVE BLOOD GLUCOSE LEVELS, PONV AND INTENSIVE CARE UNIT STAY: A PROSPECTIVE RANDOMISED 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  Dr Shubham Mittal 
Designation  PG Resident 
Affiliation  Gajra Raja Medical College 
Address  Department of Anaesthesiology, C block, 7th floor. JAH hospital

Gwalior
MADHYA PRADESH
474002
India 
Phone  9872124323  
Fax    
Email  drmittalshubham@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Goyal 
Designation  Professor and HOD 
Affiliation  Gajra Raja Medical College 
Address  Department of anaesthesia, 7th floor, C block, JAH hospital

Gwalior
MADHYA PRADESH
474002
India 
Phone  6267884654  
Fax    
Email  drpreetiravigoyal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Goyal 
Designation  Professor and HOD 
Affiliation  Gajra Raja Medical College 
Address  Department of anaesthesia, 7th floor, C block, JAH hospital


MADHYA PRADESH
474002
India 
Phone  6267884654  
Fax    
Email  drpreetiravigoyal@gmail.com  
 
Source of Monetary or Material Support  
Gajra Raja Medical College, Gwalior, MP Pincode 474002 
 
Primary Sponsor  
Name  Shubham mittal 
Address  Gajra raja medical college 
Type of Sponsor  Other [Self] 
 
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 
Dr Shubham Mittal  Gajra raja medical college  Department of Anaesthesia,7 th floor, C block
Gwalior
MADHYA PRADESH 		 09872124323

drmittalshubham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K299||Gastroduodenitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Carbohydrate drink  2 hours before operation 
Comparator Agent  Plain water  2 hours before operation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient giving consent to participate in study.
Age between 18-60 years.
ASA grade I and II.
Elective case scheduled for surgery under general anaesthesia. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare intraoperative blood glucose levels between patients
receiving preoperative carbohydrate drinks and those following
traditional fasting protocols. 		 To compare intraoperative blood glucose levels between patients
receiving preoperative carbohydrate drinks and those following
traditional fasting protocols. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence and severity of postoperative nausea and
vomiting (PONV) in both groups.
• To evaluate the impact of carbohydrate loading on length of ICU
stay. 		  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   23/03/2026 
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="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  

The study investigated the impact of preoperative carbohydrate-

rich beverage intake on intraoperative blood glucose levels, the incidence

and severity of postoperative nausea and vomiting (PONV), and the

duration of intensive care unit (ICU) stay.

1. Patient Characteristics and Study Design:

• The study included patients scheduled for elective surgery, divided

into two groups:

o Carbohydrate Group (Group A) – received a

carbohydrate-rich beverage 2 hours prior to surgery.

o Control Group (Group B) – received an equivalent volume

of plain water during the same preoperative window.

• Both groups were comparable in terms of demographic and

baseline clinical characteristics.

2. Intraoperative Blood Glucose Levels:

• Group A demonstrated more stable intraoperative blood glucose

levels compared to Group B.

• Group B showed higher variability and instances of intraoperative

hyperglycemia, potentially due to increased insulin resistance

associated with prolonged fasting.

3. Postoperative Nausea and Vomiting (PONV):

• A lower incidence and reduced severity of PONV were observed in

Group A compared to Group B.

75• Improved gastric emptying and metabolic stability in Group A may

have contributed to better postoperative comfort.

4. ICU Stay Duration:

• Group A experienced a significantly shorter duration of ICU stay

than Group B.

• This outcome may reflect enhanced postoperative recovery

associated with preoperative carbohydrate intake.

5. Complications:

• No major complications were reported in either group.

• Minor complications included:

o Transient hyperglycemia in a few patients in Group B.

o Postoperative nausea in in Group B.

• No cases of aspiration, delayed gastric emptying, or adverse

reactions to carbohydrate loading were observed, indicating a

favourable safety profile.

6. Clinical Implications:

• Preoperative carbohydrate loading appears to be a beneficial, non-

invasive intervention that supports metabolic stability, reduces

PONV, and facilitates earlier ICU discharge.

• The findings support the integration of carbohydrate loading into

Enhanced Recovery After Surgery (ERAS) protocols.


 
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