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CTRI Number  CTRI/2025/07/091483 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Taking glucose before surgery decrease the nausea and vomiting in laparoscopic surgery 
Scientific Title of Study   To study the efficacy of preoperative oral carbohydrate-rich drink on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. 
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 Sarthak Misra 
Designation  Junior resident 
Affiliation  Indira Gandhi Institute of medical sciences 
Address  Department of Anesthesiology and CCM 1st floor ward block, Indira Gandhi Institute of Medical Sciences
Indira Gandhi Institute of medical sciences
Patna
BIHAR
800014
India 
Phone  08210641979  
Fax    
Email  drsarthakmisra2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bibha Kumari 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of medical sciences 
Address  Neuro Ot Complex 1-12 1st floor ward block near Department of Anesthesia & CCM Indira Gandhi Institute of medical sciences
Indira Gandhi Institute of medical sciences
Patna
BIHAR
800014
India 
Phone  08252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bibha Kumari 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of medical sciences 
Address  Neuro Ot Complex 1-12 1st floor ward block near Department of Anesthesia & CCM Indira Gandhi Institute of medical sciences
Indira Gandhi Institute of medical sciences
Patna
BIHAR
800014
India 
Phone  08252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia & CCM, Indira Gandhi institute of Medical Sciences, Sheikhpura Patna, Bihar, India 800014 
 
Primary Sponsor  
Name  Dr Sarthak Misra 
Address  Neuro Ot Complex 1-12 1st floor ward block near Department of Anesthesia & CCM Indira Gandhi Institute of medical sciences Patna Bihar India 800014 
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 Sarthak Misra  Indira Gandhi Institute of medical sciences  Neuro Ot Complex 1-12 1st floor ward block near Department of Anesthesia
Patna
BIHAR 		 08210641979

drsarthakmisra2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee, IGIMS  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 
Intervention  Carbohydrate Rich Drink   CHD solution contains 12.5% carbohydrate, water, fructose, maltodextrin, and aromatic compounds and provides 50kcal/100ml energy. The recommended intake is 800 ml in the evening followed by 400 ml 2 hours before the surgery. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient of ASA-I, ASA-II physical status
Patients between 18-70 years of age of either sex
Patient with Mallampati Class I-II
Patients posted for laparoscopic surgeries under General Anaesthesia.
Patient willing to Participate
 
 
ExclusionCriteria 
Details  Patient ASA-3 and above.
Patient MPG 3 and above.
Patient refusal.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the severity of Postoperative nausea and vomiting (PONV).  30 minutes, 1 hour, 2 hours and 12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the duration of post-operative anti-emetic medication, need.
To assess the duration of the number of hospital days.
 		 30 minutes, 1 hour, 2 hours and 12 hours 
 
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   Phase 4 
Date of First Enrollment (India)   21/08/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsarthakmisra2021@gmail.com].

  6. For how long will this data be available start date provided 22-07-2026 and end date provided 26-07-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Post-operative nausea and vomiting (PONV) is the most reported complication that occurs after induction with general anesthesia and may result in patient discomfort, electrolyte imbalance, infections delayed recovery, and hospital discharge. CHD solution contains 12.5% carbohydrate, water, fructose, maltodextrin, and aromatic compounds and provides 50kcal/100ml energy. The recommended intake is 800 ml in the evening followed by 400 ml 2 hours before the surgery.

The aim of the study is to compare the effects of the CHD drink on PONV, consumption of antiemetic drugs and duration of hospital stay in the patients undergoing elective laparoscopic cholecystectomy.

 
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