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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  
UCMS & GTB Hospital 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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