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CTRI Number  CTRI/2018/07/014851 [Registered on: 13/07/2018] Trial Registered Prospectively
Last Modified On: 01/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessing gastric volume using ultrasound for fasting status. 
Scientific Title of Study   An interventional study comparing ultrasound guided gastric volume in patients with overnight fasting versus after ingestion of 200ml of apple juice 2 hours before non abdominal surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  YAYATI JOSHI 
Designation  DNB STUDENT 
Affiliation  SRI RAMA KRISHNA HOSPITAL 
Address  SRI RAMAKRISHNA HOSPITAL, SAROJINI NAIDU ROAD, SIDDAPUDUR, COIMBATORE

Coimbatore
TAMIL NADU
641044
India 
Phone  8593944522  
Fax    
Email  dryayatijoshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PRABHA UDAYAKUMAR 
Designation  HEAD OF DEPARTMENT 
Affiliation  SRI RAMA KRISHNA HOSPITAL 
Address  SRI RAMAKRISHNA HOSPITAL, SAROJINI NAIDU ROAD, SIDDAPUDUR, COIMBATORE

Coimbatore
TAMIL NADU
641044
India 
Phone  9095277699  
Fax    
Email  prabhadr01@gmail.com  
 
Details of Contact Person
Public Query  
Name  YAYATI JOSHI 
Designation  DNB STUDENT 
Affiliation  SRI RAMA KRISHNA HOSPITAL 
Address  SRI RAMAKRISHNA HOSPITAL, SAROJINI NAIDU ROAD, SIDDAPUDUR, COIMBATORE


TAMIL NADU
641044
India 
Phone  8593944522  
Fax    
Email  dryayatijoshi@gmail.com  
 
Source of Monetary or Material Support  
SRI RAMAKRISHNA HOSPITAL, COIMBATORE 
 
Primary Sponsor  
Name  SRI RAMAKRISHNA HOSPITAL 
Address  SAROJINI NAIDU ROAD, SIDDAPUDUR,COIMBATORE 
Type of Sponsor  Private hospital/clinic 
 
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 
YAYATI JOSHI  SRI RAMA KRISHNA HOSPITAL  SAROJINI NAIDU ROAD, SIDDAPUDUR, COIMBATORE
Coimbatore
TAMIL NADU 		 8593944522

dryayatijoshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI RAMAKRISHNA HOSPITAL ETHICAL COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA 1,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  APPLE JUICE   200 ML OF APPLE JUICE GIVEN TO ONE GROUP TWO HOURS BEFORE NON ABDOMINAL SURGERY 
Comparator Agent  APPLE JUICE  TWO HOURS PRIOR TO SURGERY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients undergoing elective non abdominal surgery under general anaesthesia..
2 Patients of age 18 to 60 years.
3 ASA Grade I patients.
4 Patients who provides consent
5 Patients with BMI < 30kg/m2 
 
ExclusionCriteria 
Details  1 Patient refusal to consent.
2 Patients with GERD.
3 Pregnant patients.
4 ASA grade ΙΙ , III and IV patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess gastric volume using ultrasonography in patients after overnight fasting and after ingestion of 200ml of apple juice 2 hours prior to surgery.  Gastric volume will be calculated using ultrasound in preoperative area before shifting to operation theatre. 
 
Secondary Outcome  
Outcome  TimePoints 
TO ASSESS pH OF GASTRIC ASPIRATE  Immediately after intubation. Ryles tube will be inserted and aspirate will be obtained to assess the pH of gastric content by standardized pH strip.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/08/2018 
Date of Study Completion (India) 15/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Study not yet started. Hence cannot be published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Perioperative aspiration of gastric contents is a rare but serious complication of anaesthesia. Fasting before general anaesthesia aims to reduce the volume and acidity of stomach contents during surgery, thus reducing the risk of regurgitation/aspiration . Hence in an attempt to reduce the fasting hours of a patient pre-operatively without increasing the risk of pulmonary aspiration we compared the gastric volume using ultrasonography and pH of gastric aspirate by pH strip in patients after overnight fasting and after ingestion of 200 ml apple juice 2 hours prior to surgery. After ethical committee approval study was started at Sri Ramakrishna Hospital, Coimbatore. Written and informed consents were taken. Duration of study was 4 months from March 2018 to June 2018. Total 50 patients were equally divided to each group by computer generated randomization. Group I included patients with over night fasting and Group II had  patients who were provided with the 200ml of apple juice 2 hours before surgery. Inclusion criteria - age 18 to 60 years, ASA I, BMI <30kg/m2 , non abdominal surgeries under general anaesthesia. Exclusion criteria - gastroesophageal reflux disease, pregnancy and ASA II III and IV. Primary objective - comparing the gastric volume using ultrasound in both groups. Secondary objective - comparing pH in both the groups.  
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