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CTRI Number  CTRI/2024/09/074060 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
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   A clinical study on the effects of Carbohydrate drink on Nausea and Vomiting in patients undergoing elective laproscopic surgeries. 
Scientific Title of Study   Comparative Study Of The Effects Of Preoperative Carbohydrate Drink On Postoperative Nausea And Vomiting In Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anaesthesia - A Randomized Double Blinded Placebo-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  Dr Bharath V 
Designation  Junior Resident 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  8892747797  
Fax    
Email  bharathvenkatesh17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa H L 
Designation  Professor 
Affiliation  BGS Global Institute of Medial Sciences 
Address  Department of Anaesthesiology, 3rd Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9916950558  
Fax    
Email  shilpahl@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shilpa H L 
Designation  Professor 
Affiliation  BGS Global Institute of Medial Sciences 
Address  Department of Anaesthesiology, 3rd Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri


KARNATAKA
560060
India 
Phone  9916950558  
Fax    
Email  shilpahl@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, 3rd Floor, Hospital building,BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060 
 
Primary Sponsor  
Name  Dr. Bharath V 
Address  Department of Anaesthesiology, 3rd Floor, Hospital building,BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060 
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 Bharath V  BGS Global Institute of Medical Sciences  Department of Anaesthesiology, 3rd Floor, Hospital building,BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri,
Bangalore
KARNATAKA 		 8892747797

bharathvenkatesh17@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: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Carbohydrate Drink  2hrs before the surgery 355mL of carbohydrate drink will be administered 
Comparator Agent  Water  2hrs before the surgery 335 ml of water will be administered 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA Grade I and II patients posted for elective laparoscopic cholecystectomy with a duration of surgery within 3 hours 2)Non smoker 3)No history of postoperative nausea and vomiting 4)No history of emetic episode in the last 24 hours
 
 
ExclusionCriteria 
Details  1)Patients with Diabetes mellitus and patients of ASA Grade III and above 2)Patients with Gastro-oesophageal reflux disease, delayed gastric emptying 3)Patients on pharmacological treatment that impairs gastrointestinal motility 4)Patients who are on treatment with Antipsychotics and steroids 5)Difficult airway 6)History of motion sickness 7)BMI more than 30 kg per meter square 8)Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of administration of preoperative carbohydrate drink on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anaesthesia.  Post operatively at 0 to 4 hours, 4 to 12 hours and 12 to 24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of preoperative carbohydrate drink on preoperative well being (where fatigue and irritability will be assessed).  Pre operatively (10 minutes before shifting to OT) 
 
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 3/ Phase 4 
Date of First Enrollment (India)   30/09/2024 
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="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   Postoperative nausea and vomiting is a common and distressing complication after anaesthesia and surgery with an incidence of approximately 30%. Although postoperative nausea and vomiting is self- limiting and non fatal, it is unpleasant and is a greater concern than postoperative pain. Preoperative carbohydrate drink has shown to reduce the risk of postoperative nausea and vomiting and helps in improving the preoperative patient comfort. Although this concept of preoperative carbohydrate drink is being used, there are not many studies in which preoperative carbohydrate drink is used to prevent postoperative nausea and vomiting and preoperative comfort, hence we are planning to conduct a clinical study on this.  
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