| CTRI Number |
CTRI/2024/03/064742 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
comparative |
| Study Design |
Other |
|
Public Title of Study
|
Compare the risk of aspiration in patients undergoing elective surgery between Patient without Diabetes and patients with Diabetic related with nerve pain or damage |
|
Scientific Title of Study
|
Comparison of ultrasound guided residual gastric volume measurement between diabetic with autonomic neuropathy and non-diabetic patients scheduled for elective surgery under general anesthesia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harinishaanth B |
| Designation |
Second year post graduate resident M.D Anesthesiology |
| Affiliation |
Sri Ramachandra Institute of higher education |
| Address |
G block ROOM 139 Ramachandra Hostel
Sri Ramachandra Institute of Higher Education ,Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
09677633197 |
| Fax |
|
| Email |
harinishaanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mahesh Vakamudi |
| Designation |
Professor M.D Anesthesiology |
| Affiliation |
Sri Ramachandra Institute of higher education |
| Address |
Room no A6 Anaesthesia department
Sri Ramachandra Institute of Higher education
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
vakamudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Mahesh Vakamudi |
| Designation |
Professor M.D Anesthesiology |
| Affiliation |
Sri Ramachandra Institute of higher education |
| Address |
Room no A6 Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and Research,porur
Chennai
TAMIL NADU
600116
India |
| Phone |
09677633197 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR, CHENNAI-600116 |
|
|
Primary Sponsor
|
| Name |
DRHARINISHAANTH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ,CRITICAL CARE AND PAIN MEDICINE,RAMACHANDRA INSTITUE OF HIGHER EDUCATION AND RESEARCH |
| Type of Sponsor |
Other [SELF FINANCING] |
|
|
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 |
| DRHARINISHAANTH |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
DEPARTMENT OF ANAESTHESIA,OPERATING ROOMS DIVISION,ROOM NUMBER A6
Chennai
TAMIL NADU |
9677633197
harinishaanth@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMACHANDRA INSTITUTIONAL RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
both male and female above 18 years |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ANALYSE BETWEEN BOTH DIABETIC AND NON-DIABETIC FOR RISK OF ASPIRATION |
AT BASELINE BEFORE INDUCTION OF GENERAL ANAESTHESIA AT 0 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POST OP VOMITTING |
AFTER SURGERY |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2024 |
| Date of Study Completion (India) |
28/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
TO ANALYSE BETWEEN BOTH GROUPS FOR RISK OF ASPIRATION BETWEEN DIABETIC AND NON-DIABETIC PATIENTS Background-As there is no proper guidelines regarding adequate Nil per oral status for patient undergoing General Anaesthesia and foremost important complication is Aspiration of Gastric contents
Purpose-Patient with Long standing Diabetes can have impaired or delayed Gastric emptying for which the Nil per Oral has to be prolonged for such patients |