| CTRI Number |
CTRI/2025/07/090123 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| 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
|
A study comparing the risk of having full Stomach during anaesthesia in children Who fast for shorter vs. longer times before surgery |
|
Scientific Title of Study
|
Comparison of Incidence of High Risk Stomach in Minimally Fasted with Conventionally Fasted Paediatric Patients Posted for Elective Surgery: A Prospective, Randomized, Single Blinded 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 |
Rakshith M Adiga |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Senior Resident (Acad) Paediatric anaesthesiology
Department of Anaesthesiology
Level 6, Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9481960443 |
| Fax |
|
| Email |
rmadiga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology
Level 6, Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakshith M Adiga |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Senior Resident (Acad) Paediatric anaesthesiology
Department of Anaesthesiology
Level 6, Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9481960443 |
| Fax |
|
| Email |
rmadiga@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh
All India Institute of Medical Sciences · Virbhadra Road, Rishikesh · Uttarakhand- 249 203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Rishikesh |
| Address |
All India Institute of Medical Sciences · Virbhadra Road, Rishikesh · Uttarakhand- 249 203 |
| 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 |
| Rakshith M Adiga |
All India Institute of Medical Sciences, Rishikesh |
Main OT, OR 2-10, Level 6, Block B
All India Institute of Medical Sciences · Virbhadra Road, Rishikesh · Uttarakhand- 249 203
Dehradun
UTTARANCHAL |
9481960443
rmadiga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (3) ICD-10 Condition: B67||Echinococcosis, (4) ICD-10 Condition: J85-J86||Suppurative and necrotic conditions of the lower respiratory tract, (5) ICD-10 Condition: J90-J94||Other diseases of the pleura, (6) ICD-10 Condition: C00-D49||Neoplasms, (7) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (8) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (9) ICD-10 Condition: E20-E35||Disorders of other endocrine glands, (10) ICD-10 Condition: E00-E07||Disorders of thyroid gland, (11) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional fasting |
Will receive standard NPO instructions: 8 hours for solid foods, 6 hours for milk and formula feeds, and 2 hours for liberal clear fluids prior to surgery |
| Intervention |
Minimal Fasting |
Will receive NPO instructions: 8 hours for solid foods, 6 hours for milk and formula feeds, and 2 hours for liberal clear fluids. Following this, sips of clear fluid( water/ 5%dextrose) upto 3ml/kg/hour, not more than 30ml/hour until being shifted from ward to preoperative area |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Posted for elective surgery |
|
| ExclusionCriteria |
| Details |
Past H/O abdominal surgery
H/O gastrointestinal disorders, GERD, achalasia cardia
Anticipated difficult airway
Prior H/O pulmonary aspiration
Presence of delayed development or neurological impairment
Last case of the list |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence or absence of high risk stomach, defined as gastric content more than 1.25ml/kg measured using gastric ultrasound in right lateral decubitus position |
Immediately after being shifted to preoperative area from the ward. Only one reading will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Volume of gastric content measured using gastric ultrasound in right lateral decubitus position |
On being shifted to preoperative area from the ward. If the first reading shows high risk stomach, second reading will be taken after a period 2 hours is passed after the previous sip of water |
| Anxiety level using mYAS tool |
On being shifted to preoperative area from the ward, prior to measuring gastric volume. Only a single reading will be taken |
| Exact duration of NPO, for solids & clear fluids |
At the time of induction, just before starting pre oxygenation.
Only one single reading will be noted |
| Serum cortisol |
Post induction, prior to surgical incision. Only one single sample will be drawn |
| Any adverse events like vomiting, aspiration, desaturation, bronchospasm, laryngospasm |
During the period of induction till starting of surgery |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
14/07/2025 |
| 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="6"
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
|
Preoperative fasting reduces the risk of aspiration during anaesthesia, but prolonged fasting in children can lead to discomfort, anxiety, and doesn’t always guarantee an empty stomach. Gastric ultrasound is a reliable, non-invasive method for assessing gastric volume, with >1.25 ml/kg considered high risk for aspiration. This study compares gastric volumes in two pediatric groups ages 2-12 years posted for elective surgery: -
Group C (Conventional Fasting): Standard fasting—8 hrs for solids, 6 hrs for milk/formula, 2 hrs for clear fluids. -
Group M (Minimal NPO): Same instructions for solid/milk fasting, but allowed sips of water (up to 3 ml/kg/hr, max 30 ml/hr) until transfer to OR. All patients receive IV fluids according to Holliday-Segar formula. Gastric volume is measured using ultrasound in the pre-op area by a blinded investigator, with calculations based on CSA and Spencer’s formula - Volume = -7.8 + (3.5 × RLD CSA) + (0.127 × age in months). Volume of 1.25ml/kg is taken as threshold for high risk stomach. Anxiety is assessed using mYAS; Serum cortisol is measured post-induction. Additionally, adverse events if any, during induction are noted. Method of induction and the choice of airway device will be as per the plan of the anaesthesiologist managing the patient. If gastric volume exceeds the high-risk threshold and the last intake is too recent, surgery is postponed and reassessment is done. If risk persists despite adequate fasting, a modified rapid sequence induction (RSI) is performed, with intubation and gastric suction. All randomized patients are included in the final analysis, regardless of gastric volume at first scan. |