| CTRI Number |
CTRI/2023/08/057063 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
USG Guided comparison of Residual Gastric volume in diabetic vs Nondiabetic patients undergoing elective surgeries. |
|
Scientific Title of Study
|
Preoperative Gastric volume estimation in Diabetic vs Nondiabetic patients undergoing elective surgeries-A Prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nimisha C |
| Designation |
post graduate student |
| Affiliation |
AIIMS Raipur |
| Address |
B-Block OT complex
4th floor, B block
AIIMS Raipur
Tatibandh
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
7034543334 |
| Fax |
|
| Email |
nimishanoufal333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Dubey |
| Designation |
Additional professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Anaesthesiology,
AIIMS Raipur,
Raipur,
Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8839829867 |
| Fax |
|
| Email |
drrashmi1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Dubey |
| Designation |
Additional professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Anaesthesiology
AIIMS Raipur
Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8839829867 |
| Fax |
|
| Email |
drrashmi1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
AIIMS RAIPUR,
Tatibandh,
Raipur
Chhattisgarh |
| 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 Nimisha C |
AIIMS RAIPUR |
Preoperative Area
4 th Floor OT Complex
A Block
Department of Anaesthesiology
Raipur
CHHATTISGARH |
7034543334
nimishanoufal333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II & III
non GI surgeries
elective surgeries
undergoing spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
patient refusal
patient with diagnosis of shock and sepsis
inability to measure gastric volume
pregnant female
patient with GERD or upper abdominal surgeries
previous GI surgeries
BMI > 35 kg/m2
duration of Diabetes less than 5 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
residual gastric volume will be assessed and compaired between diabetic vs nondiabetic Patients after 8 hours of fasting.
study will assess wheather diabetis will cause delaying of gastric emptying time. |
residual gastric volume will be assessed after 8 hours of fasting and after 2 hours of drinking of clear liquid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relationship between glycosilated hemoglobin,duration of diabetes and gastric emptying in the diabetic population, to assess wheather there is any relationship when higher the value of HbA1C and long duration of diabetes with delaying of gastric emptiying time |
relation will be assessed in patients with history of diabetes more than 5 years and
HbA1C will be tested before surgery and USG assessment . |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/09/2023 |
| 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
|
not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tittle of the study : preoperative gastric volume estimation in diabetic vs nondiabetic patients undergoing elective surgeries.Participant will be recruited according to inclusion criteria. Preoperatively after 8 hours of fasting , gastric volume estimation will be done with a USG machine ,then patient will be provided with 200 ml of plain water orally and repeat USG will be done after 2 hours. gastric volume will be estimated and compared between diabetic and non diabetic patients. the expected outcome of the study will be gastric emptying will be delayed in diabetic patients due to autonomic gastropathy and it can leads to increased chance of pulmonary aspiration perioperatively in patients undergoing general anesthesia.
|