CTRI Number |
CTRI/2021/04/032882 [Registered on: 16/04/2021] Trial Registered Prospectively |
Last Modified On: |
29/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Observational |
Study Design |
Other |
Public Title of Study
|
Comparison study between preoperative standard fasting hours and gastric aspirate pH in paediatric age group |
Scientific Title of Study
|
Comparative study of residual gastric volume using ultrasound following preoperative fasting regimen of 6hr-4hr-2hr in paediatric age group undergoing general anaesthesia and relation with gastric pH;A hospital based prospective, observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrRhea Thotungal |
Designation |
Academic junior resident |
Affiliation |
All india institute of medical sciences,Bhopal |
Address |
Aiims pg girls hostel, aiims bhopal,saketh nagar AIIMS BHOPAL,saketh nagar,462021 Bhopal MADHYA PRADESH 462021 India |
Phone |
7225800624 |
Fax |
|
Email |
rheat1992@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jai prakash sharma |
Designation |
Professor,department of anaesthesiology and critical care |
Affiliation |
AIIMS BHOPAL |
Address |
AIIMS BHOPAL,SAKETH NAGAR,462020 Aiims pg girls hostel, aiims bhopal,saketh nagar Bhopal MADHYA PRADESH 462020 India |
Phone |
9425609647 |
Fax |
|
Email |
drjpsharma100@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jai prakash sharma |
Designation |
Professor,department of anaesthesiology and critical care |
Affiliation |
AIIMS BHOPAL |
Address |
AIIMS BHOPAL,SAKETH NAGAR,462020 Aiims pg girls hostel, aiims bhopal,saketh nagar Bhopal MADHYA PRADESH 462020 India |
Phone |
9425609647 |
Fax |
|
Email |
drjpsharma100@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
DrJai prakash sharma |
Address |
Professor,Department of Anaesthesiology,AIIMS BHOPAL |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
DrPoojs singh |
Associate professor,department of anaesthesiology,AIIMS BHOPAL |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
J p sharma |
All india institute of medical sciences,bhopal |
Department of anaesthesiology and critical care, modular operation theatre,2nd floor,AIIMS hospital Bhopal MADHYA PRADESH |
9425609647
drjpsharma100@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IHEC-PGR, AIIMS BHOPAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (3) ICD-10 Condition: N50||Other and unspecified disorders ofmale genital organs, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ultrasound guided gastric antrum volume assessment and gadtric ph |
Ultrasound guided gastric volume assessment after following preoperative fasting of 6hr,4hr and 2hrs and once patient is given general anaesthesia gastric aspirate is taken |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
Asa 1 and asa 2 patients undergoing general aneathesia |
|
ExclusionCriteria |
Details |
Age less than 6yrs & more than 18yrs
Patients with gastroesophageal disease
Patients with poor GCS
Patients undergoing emergency procedure |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare the residual gastric volume following preoperative fasting regimen and realtion with gastric ph |
6hrs after fasting for solids
4hrs for liquids
2hrs for clear water |
|
Secondary Outcome
|
Outcome |
TimePoints |
To calculate residual gastric volume using ultrasonography in paediatric and adolescent age group
To find if there is any relationship between residual gastric volume and preoperative dasting hours |
6hrs after fasting for solids
4hrs after fasting for liquids
2hrs fasting for clear water |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
30/04/2021 |
Date of Study Completion (India) |
31/12/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Preoperative fasting is an important step to prevent postoperative complications like aspiration,post operative nausea,vomiting etc.Since Mendelson’s publication of the article regarding fatal consequences of aspiration of gastric contents preoperative fasting guidelines have evolved over the years.Presently the guidelines : 6hrs for solids,4hrs for liquids and 2hrs for clear fluids are followed internationally.But it is noticed that there is an excessive fasting time among patients as a result of fear of postponement of surgery,miscommunication etc.Though recent studie have shown that there is not much increase in incidence of aspiration in children who are allowed to take fluids upto 1 hour prior to surgery the data is limited.So with this study we are aiming to assess the gastric volume at different hours of preoperative fasting using ultrasound in prescribed age group and to see if there is any relationship between gastric ph and gastric volume.Our hypothesis is that if there is no considerable change in the gastric ph there is provision to decrease our standard fasting hours. |