| CTRI Number |
CTRI/2024/06/068716 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Measurement of Stomach Volumes in children undergoing operation after intake of water or Apple juice, using ultrasound machine |
|
Scientific Title of Study
|
Assessment of Gastric Volumes in Preoperative Paediatric surgical patients with intake of water or Apple juice- An ultrasound based randomised 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 Lakshmegowda C A |
| Designation |
Junior Resident in Department of Anaesthesiology and Critical Care |
| Affiliation |
Vijayanagar Institute of Medical Sciences Ballari |
| Address |
Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9108345003 |
| Fax |
|
| Email |
lakshmegowda10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lakshmegowda C A |
| Designation |
Junior Resident in Department of Anaesthesiology and Critical Care |
| Affiliation |
Vijayanagar Institute of Medical Sciences Ballari |
| Address |
Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences,Cantonment, Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9108345003 |
| Fax |
|
| Email |
lakshmegowda10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bala Bhaskar S |
| Designation |
Professor |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Dep of Anaesthesiology
Vijayanagar Institute of Medical Sciences
Ballari
Bellary KARNATAKA 583103 India |
| Phone |
9880012349 |
| Fax |
|
| Email |
sbalabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care
Vijayanagar Institute of Medical Sciences, Cantonment, Ballari 585104 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshmegowda C A |
Vijayanagar Institute of Medical Sciences |
Department of Anaesthesiology and Critical Care, Major OT Complex, Cantonment, Ballari 583104 Bellary KARNATAKA |
9108345003
lakshmegowda10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Vijayanagar Institute of Medical Sciences, Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apple group |
Apple Juice at 3 ml/kg administered at 7 AM (2 hours before surgery). Gastric assessment performed at 7 AM and every 30 mins till 9 AM
Total duration- 2hrs |
| Comparator Agent |
Water group |
Water at 3 ml/kg administered at 7 AM (2 hours before surgery). Gastric assessment performed at 7 AM and every 30 mins till 9 AM
Total duration - 2hrs |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age 4 to12 years, of either gender admitted for elective surgeries with overnight inpatient stay preoperatively and 8 hours of fasting.
2. ASA physical status I and II |
|
| ExclusionCriteria |
| Details |
1.Patient / parent /LAR refusal for procedure.
2.Deviation from proposed fasting guidelines or oral intake advise.
3.Subjects with gastric motility disorders.
4.Subjects prone for aspiration.
5.Subjects on drugs that might affect gastric emptying |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gastric volume at 2 hours after intake of water or apple juice |
0 time (7 AM) every 30min for 2 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Basal gastric volume (gastric volume after overnight fasting) & gastric after ingestion of liquids at 30min, 60min, 90min, & 120min.
2 Gastric Antral CSA at different time intervals
3 Non - acceptability of drink by children
4 Post operative nausea & vomiting
5 Glucometric random blood sugar levels after induction |
Basal gastric volume (gastric volume after overnight fasting) & gastric after ingestion of liquids at 30min, 60min, 90min, & 120min.
At 7:00AM (Basal) serial ultrasounds every half hourly following blender coconut water consumption 7:30AM 8:00AM 8:30AM 9:00AM
7AM
6 Hours following surgery
After induction of Anaethesia |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="6" 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
|
Pre operative mandatory fasting is a safety precaution intended to decrease gastric content and improve pH to protect from regurgitation and pulmonary aspiration under anaesthesia and deep sedation gastric emptying depends on type and volume of different contents as well as time duration since last intake. Perioperative pulmonary aspiration though not frequent (0.020.1%), is a serious anaesthetic complication with morbidity and mortality. Aspiration risk is especially corelated to duration of fasting in all age groups including paediatric population.
Indian Society of Anaesthesiologists [ISA] has laid down mandatory NPO guidelines according to which 6 hours fasting for solid food and non-human milk, 4 hours for breast milk, water up to 3ml/kg body weight allowed till 1 hour prior to administration of anaesthesia and for clear liquids other than water (up to 3ml/kg) till 2 hours prior to administration of anaesthesia in paediatric population.
American Society of Anesthesiologists [ASA] preoperative fasting guidelines for paediatric population recommends 2 hours of fasting for clear fluids, while another the recent guidelines mentions that there is insufficient evidence concerning clear liquid 1 hour prior to anaesthesia.
The more recent guidelines of European Society of Anaesthesiology and Critical Care for paediatric population highly recommends that healthy children be encouraged to drink clear fluids (including water with or without sugar, pulp free fruit juices, and milk free tea or coffee) up to 1 hour before anaesthesia induction for elective procedures, but with low-quality evidence.
Undue prolongation of fasting period in children is observed due to many factors which may lead to dehydration, hypoglycaemia, patient anxiety and discomfort. ERAS protocols for paediatric population advise that the child consumes a preoperative carbohydrate-rich drink 2 hours prior to surgery at home or in the preoperative holding area along with other premedication with overall goal of reducing the negative effects of anaesthetic and surgical intervention so that patients can recover quickly with fewer complications and have greater satisfaction.
A few prospective observational studies and RCTs have compared preoperative carbohydrate oral drinks and clear liquids such as apple juice and observed that residual gastric volume will be same or lesser compared to group not having clear fluids, with better patient satisfaction, overall well-being, reduced PONV, less antiemetic use, better perioperative glycemic profile without risk of pulmonary aspiration. Gastric sonography is a bed side non-invasive, point of care tool that can reliably provide valuable information related to both the quantitative and qualitative aspects of gastric contents.
Study of gastric emptying with respect to Indian paediatric population is inadequate, hence this study aims to evaluate influence of preoperative water or apple juice as the clear fluid on gastric volume at 2 hour by ultrasonography as the primary objective. |