| CTRI Number |
CTRI/2025/04/084304 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Chewing Gum eating on Stomach Volume before Operation in Head Surgery patients assessed by Ultrasound |
|
Scientific Title of Study
|
Role of Preoperative Use of Sugarless Chewing Gum on Gastric Volume as Assessed by Ultrasound in Patients undergoing Craniotomy- A Prospective Randomized Control Trail |
| 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 Chanchal Jattayan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9149195503 |
| Fax |
|
| Email |
bs72701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Agrawal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Agrawal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , AIIMS Rishikesh , Virbhadra Road , Rishikesh , Dehradun , Uttaranchal 249203 India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Chanchal Jattayan |
OT Complex |
Level 6 , Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL |
9149195503
bs72701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chewing gum |
Patients will be given chewing gum to chew and gastric volume will be measured before induction in OT and after surgery is completed |
| Comparator Agent |
No chewing gum |
Patients gastric volume will be measured before induction in OT and after surgery is completed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Grade 1 and 2 , BMI 25-30 , GCS more than or equal to 14 , Supratentorial lesions, undergoing elective craniotomy surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal , Regular Smokers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gastric volume in the patients |
Before Surgery and After Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative Anxiety in the patients |
Preoperative period |
| Incidence and frequency of Nausea and Vomiting in the patients |
Postoperative period |
|
|
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)
|
21/04/2025 |
| 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="0"
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
|
Adequate NPO in the Preoperative period leads to less gastric volume and reduced chances of aspiration . We want to study the effect of chewing gum in the preoperative period on gastric volume by using USG in patients going for craniotomy |