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CTRI Number  CTRI/2024/12/078083 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oral Carbohydrate fluid will be given before procedure under Anaesthesia]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial in cirrhotic patients to see Gastric emptying time after clear carbohydrate fluid administration undergoing endoscopic procedures under Anaesthesia, to help improve perioperative wellbeing. 
Scientific Title of Study   Gastric emptying time after clear fluid administration in cirrhotic patients undergoing endoscopic procedures under Anaesthesia: A randomised 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 Heena Saghavi 
Designation  Senior Resident 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi

South
DELHI
110070
India 
Phone    
Fax    
Email  heenasanghavi2504@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Tempe 
Designation  Head of Department 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi

South
DELHI
110070
India 
Phone  9718599401  
Fax    
Email  tempedeepak@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Tempe 
Designation  Head of Department 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi

South
DELHI
110070
India 
Phone  9718599401  
Fax    
Email  tempedeepak@hotmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi 110070 
 
Primary Sponsor  
Name  Institue of Liver and Biliary Sciences. 
Address  Dept of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi- 110070 
Type of Sponsor  Research institution and hospital 
 
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 Heena Sanghavi   Institute of Liver and Biliary Sciences   Dept of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi 110070
South
DELHI 
07798630238

heenasanghavi2504@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ILBS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2 hours fasting group   65 Patients of this group will receive oral clear 250ml apple juice and gastric ultrasound will be done after 2 hours to look for gastric emptying, then endoscopy will be done if empty, if not, hourly gastric ultrasound will be done, till stomach is empty. 
Comparator Agent  3 hours fasting group  65 Patients of this group will receive oral clear 250ml apple juice and gastric ultrasound will be done after 3 hours to look for gastric emptying, then endoscopy will be done if empty, if not, hourly gastric ultrasound will be done, till stomach is empty. 
Comparator Agent  more than 6 hours fasting group  65 Patients of this control group will not receive oral juice and directly gastric ultrasound will be done for gastric emptying, then endoscopy will be done if empty, if not, hourly gastric ultrasound will be done, till stomach is empty. 
Intervention  Oral carbohydrate fluid will be given in 3 groups.  3 groups- 6 hours, 3 hours, 2 hours fasting group will undergo ultrasound for gastric emptying before endoscopic procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Cirrhotic patients,
Patients undergoing Endoscopy, Endoscopic retrograde cholangiopancreatography, Endoscopic ultrasound. 
 
ExclusionCriteria 
Details  Acute variceal bleed
Hepatic encephalopathy
Diabetes Mellitus
Patient refusal.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare gastric emptying time in 3 groups  From 6 hours before procedure to 1 hour post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Patient well-being,
Hemodynamic status,
Postoperative complications 
Upto 1 hour postoperatively 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="195" 
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)   01/01/2025 
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="0"
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 - NO
Brief Summary  

Prior to procedure, a brief pre-anaesthetic evaluation will be done. Intravenous access will be secured. Patients will be randomly assigned to one of the 3 groups: the control group (>6 hours), and intervention groups of 2 h and 3 h (n = 65 each).

The intervention group will receive 250ml carbohydrate fluid (apple juice) 2 h or 3h prior to the scheduled endoscopic procedure, and control group will receive nothing.

Preoperative wellbeing will be assessed, and Gastric ultrasound will be done in supine and right lateral position. Perioperative patient wellbeing will be assessed as VAS score for- Thirst, Hunger, Headache, Nausea/ vomiting, Weakness/ fatigue and Dryness of mouth.

Gastric volume will be predicted by 3-point grading system

grade 0- empty stomach (empty antrum in both the supine and right lateral positions)

grade 1- minimal fluid < 100ml (volume detected only in the right lateral position)

grade 2 - higher fluid volumes (>100 ml) antrum distended with fluid in both supine and right lateral positions, higher risk of regurgitation of gastric contents on induction of anaesthesia

Grade 1 and 2 patients will be assessed again after 1 hr and will be taken after Grade 0. Grade 0 patients will be taken for procedure.

In the endoscopy room, standard monitoring devices will be attached. Oxygen supplementation at 4 L/min will be administered through nasal cannula. With the patients in the left lateral position, induction will be done with intravenous propofol (1.5-2 mg/kg). Endoscopy will be performed and fluid if present, will be aspirated and calculated.

Gastric fluid >/= 1.5ml/kg will be considered as high risk for bronchoaspiration. Intraprocedural Hemodynamics will be assessed at 0, 1 and 5 mins by measuring mean arterial pressure (MAP), SpO2, and HR. Patients will be assessed post procedure for any complications and patient wellbeing in terms of thirst, hunger, headache, nausea, vomiting, weakness, fatigue and dryness of mouth. 

 
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