| CTRI Number |
CTRI/2025/12/099709 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Chewing a Gum on Stomach Volume in a Fasted Diabetic Patient - A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect Of Gum Chewing On Gastric Antral Volume In Fasted Diabetic Patients: A Randomized 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 |
SWATI JAIN |
| Designation |
Assistant Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
| Address |
Department of Anaesthesiology and Critical Care,
UCMS and GTB Hospital,
Dilshad Garden, Delhi - 110095
East
DELHI
110095
India |
| Phone |
9810613597 |
| Fax |
|
| Email |
drswatijain273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SWATI JAIN |
| Designation |
Assistant Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
| Address |
Department of Anaesthesiology and Critical Care,
UCMS and GTB Hospital,
Dilshad Garden, Delhi - 110095
East
DELHI
110095
India |
| Phone |
9810613597 |
| Fax |
|
| Email |
drswatijain273@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATI JAIN |
| Designation |
Assistant Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
| Address |
Department of Anaesthesiology and Critical Care,
UCMS and GTB Hospital,
Dilshad Garden, Delhi - 110095
East
DELHI
110095
India |
| Phone |
9810613597 |
| Fax |
|
| Email |
drswatijain273@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi - 110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital
Dilshad Garden,
Delhi - 110095 |
| 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 Swati Jain |
University College of Medical Sciences And Guru Teg Bahadur Hospital, Dilshad Garden,Delhi - 110095 |
Operation Theater Complex
East
DELHI |
9810613597
drswatijain273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Teg Bahadur Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chewing Gum |
Effect of Chewing Gum on residual gastric volume in preoperative period at the end of first and second hour |
| Comparator Agent |
No Chewing Gum |
Effect of residual gastric volume in the preoperative period using USG (POCUS-G) at first and second hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients of either sex with Body Mass Index - 18 to 35 kilogram per meter square aged 18-80 years
American Society of Anesthesiologist physical status - I–III
Diabetes Mellitus |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if Pregnant or having diabetes mellitus trauma patients having recent upper gastrointestinal bleed previous gastric or lower esophageal surgery documented abnormalities of upper gastrointestinal tract such as hiatal hernia and gastric tumors
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the effect of chewing gum (CG) on the gastric antral volume (GAV) at the end of first hour between the two groups. |
1st hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To determine Gastric antral volume at the end of 2nd hour
2) Preoperative anxiety at Baseline and at 2nd hour of gum chewing using (Amsterdam Perioperative Anxiety and Information Scale)
3) PONV score at the end of 1st, 4th, 6th, 12th and 24th hour post-operatively
4) Thirst and hunger score at baseline and at the end of 2nd hour before the patient is wheeled into the OT
5) QoR – 15 score at baseline and at the end of day one |
2nd Hour
0 Hour and 2nd hour
1st, 4th, 6th, 12th and 24th hour
0 hour and 2nd hour
24th hour
|
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
02/02/2026 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data will indefinitely be available on request to mail id - drswatijain273@gmail.com
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The use of Chewing gum (CG) in perioperative setting has several advantages. It includes allaying anxiety, decreasing the incidence of postoperative nausea and vomiting (PONV) and reducing the feeling of thirst and hunger in the perioperative period. An important concern with its use is increased gastric antral volume (GAV) which could be detrimental in the perioperative setting; more so, in patients with high risk of regurgitation and aspiration. While some studies report a small but statistically significant increase in gastric volume (GV) with CG, others suggest neither gastric volume nor pH is significantly affected. No study has explored the influence of CG on GV in fasted diabetic patients; the benefits of CG in diabetic patients has also not been studied.
We aim to compare and evaluate the influence of chewing gum on gastric antral volume in diabetic patients undergoing elective surgery
|