| CTRI Number |
CTRI/2023/07/055882 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare gastric volume in diabetic patients after overnight fasting and after ingestion of clear liquids two hours before surgery using ultrasound |
|
Scientific Title of Study
|
Randomised clinical trial to compare ultrasonography guided gastric volume in diabetic patients after overnight Fasting and after ingestion of clear liquids two hours before surgery |
| 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 Koushallya Sri S |
| Designation |
Second year postgraduate |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Department of Anaesthesiology
Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
7299224444 |
| Fax |
|
| Email |
akskoush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand S |
| Designation |
Professor |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Department of Anaesthesiology Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koushallya Sri S |
| Designation |
Second year postgraduate |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Department of Anaesthesiology Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
7299224444 |
| Fax |
|
| Email |
akskoush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam |
|
|
Primary Sponsor
|
| Name |
Chettinad hospital and research institute |
| Address |
Chettinad Academy of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam ,603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Koushallya Sri S |
Chettinad Hospital and Research Institute |
Department of anaesthesia ,A block ,2nd floor Chettinad Academy of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam ,603103
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7299224444
akskoush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics committee for student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diabetic patient who received water 2 hours preoperatively |
Diabetic patient who fasted overnight and will receive 150 ml water 2 hours preoperatively |
| Intervention |
Overnight fasted diabetic patients |
Diabetic patient who fasted for 8 hours overnight |
| Comparator Agent |
The residual gastric volume in diabetic patients who fasted overnight and who ingested water 2 hours preoperatively presenting for elective surgeries .
|
Group 1 - Diabetic patient who fasted for 8 hours overnight
Group 2 - Diabetic patient who fasted overnight and will receive 150 ml water 2 hours preoperatively |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 30 - 70 years with diabetes 2. Both sexes 3. ASA Classes II and III patients 4. Patients posted for elective surgeries
5. Definitive diagnosis of T2DM for > 5 years |
|
| ExclusionCriteria |
| Details |
Pregnancy
cardiac or renal dysfunction
Hypothyroidism
Obesity (BMI > 35 kg/m2)
Digestive system diseases, including gastroesophageal reflux, peptic ulcer, digestive system tumors, cholelithiasis or history of upper gastrointestinal surgery
Receiving antiemetic drugs or other drugs affecting gastrointestinal motility before operation
Preoperative gastrointestinal decompression or nutrition
Unwilling to participate in the study
ASA Class IV patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the residual gastric volume in right lateral decubitus position |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the antral cross-sectional area in semi-sitting position
To compare the antral cross-sectional area in right lateral decubitus position |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/08/2023 |
| 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="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of this study was to determine, with the help of ultrasound, the residual gastric volume in diabetic patients who fasted overnight and who ingested water 2 hours preoperatively presenting for elective surgeries .
Objectives Primary objective To compare the residual gastric volume in right lateral decubitus position
Secondary objective To compare the antral cross-sectional area in semi-sitting position To compare the antral cross-sectional area in right lateral decubitus position
Group 1 - Diabetic patient who fasted for 8 hours overnight
Group 2 - Diabetic patient who fasted overnight and will receive 150 ml water 2 hours preoperatively |