| CTRI Number |
CTRI/2025/08/093778 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF GUM CHEWING ON RESIDUAL GASTRIC VOLUME IN FASTING OBESE PATIENTS BEFORE SURGERY
|
|
Scientific Title of Study
|
EFFECT OF GUM CHEWING ON RESIDUAL GASTRIC VOLUME IN FASTED OBESE 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 |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
UCMS & GTB Hospital |
| Address |
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
East DELHI 110095 India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetnjalidr@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
UCMS & GTB Hospital |
| Address |
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
DELHI 110095 India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetnjalidr@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Arunima Singh |
| Designation |
PG student |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
East DELHI 110095 India |
| Phone |
09711210772 |
| Fax |
|
| Email |
arunima.singh0204@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi |
| 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 Arunima Singh |
University College of medical science and GTB hospital |
Main ICU second floor Department of Anesthesiology and critical care OT block university college of medical science and GTB hospital Dilshad garden East DELHI |
09999945281
arunima.singh0204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committe human research |
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: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO CHEWING GUM |
EFFECT OF RESIDUAL GASTRIC VOLUME IN THE PREOPERATIVE PERIOD USING USG (POCUS-G) AT FIRST AND SECOND HOUR |
| Intervention |
CHEWING GUM |
EFFECT OF CHEWING GUM ON RESIDUAL GASTRIC VOLUME IN PREOPERATIVE PERIOD AT THE END OF ONE AND TWO HOUR |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients of either sex with BMI more than 30kg/m2 aged 18-60 years ASA I-III undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
patients will if excluded if Pregnant or having diabetes mellitus trauma patients 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
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Residual gastric volume using USG (POCUS-G)
|
Residual gastric volume using USG (POCUS-G) at the end of one hour of gum chewing
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Residual gastric volume
APAIS
PONV score
Thirst score and Hunger score
QoR – 15 score
Sore throat and Hoarseness
|
Residual gastric volume at the end of 2nd hour
APAIS Baseline and at 2nd hour of gum chewing
PONV score at the end of 1st, 4th, 6th and 12th and 24th hour post-operatively
Thirst score and Hunger score at baseline and at the end of 2nd hour
QoR – 15 score at baseline and at day one
Sore throat and Hoarseness at day one
|
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/09/2025 |
| 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="5" 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
|
Patients will be randomized in one of the two groups i.e. Group CG where
patients will chew a sugar free gum for one hour and Group NG where no gum will
be chewed. All patients will be assessed for Baseline residual gastric volume using point-of-care gastric
ultrasound (POCUS-G) (V0), Quality of Recovery-15 (QoR-15), Anxiety using
Amsterdam peri-operative anxiety scale (APAIS) at the beginning of the study in
the preoperative room as baseline. Thirst score and Hunger
score will be recorded as baseline. Thereafter, they will be asked to chew a sugar-free gum
for an hour. After one hour, the gum will be removed and residual gastric volume will be assessed
at the end of 1st hr and then at the end of 2nd hr. After
the second residual gastric volume assessment, anxiety assessment using APAIS will be done along
with Thirst score and Hunger score before the patient is wheeled in the OT. In
the postoperative period, PONV score at 1st, 4th, 6th,
12th and 24th hour, QoR-15 score at the end of day1 will
be assessed.
The primary outcome will be residual gastric volume at the end of 1st hour.
The secondary outcomes will be residual gastric volume at the end of 2nd hour, APAIS
Baseline and at 2nd hour of gum chewing, PONV score at the
end of 1st, 4th, 6th and 12th and
24th hour post-operatively, Thirst score and Hunger score
at baseline and at the end of 2nd hour, QoR – 15
score at baseline and at day one Sore throat and Hoarseness at day
one. |