| CTRI Number |
CTRI/2020/11/029391 [Registered on: 26/11/2020] Trial Registered Prospectively |
| Last Modified On: |
25/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing stomach volume of fasting and non fasting patients by sonography |
|
Scientific Title of Study
|
A Comparative preoperative ultrasound guided assessment of gastric volume and contents in adult patients with 2 hours fasting for clear liquids receiving metoclopramide versus overnight fasted patients- A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Singh Baghela |
| Designation |
PG Student |
| Affiliation |
Dr S.N.Medical college, jodhpur, Rajasthan |
| Address |
Department of anaesthesiology, Dr. S.N.Medical college jodhpur Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414127101 |
| Fax |
|
| Email |
ajitsinghbaghela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajit Singh Baghela |
| Designation |
PG Student |
| Affiliation |
Dr S.N.Medical college, jodhpur, Rajasthan |
| Address |
Department of anaesthesiology, Dr. S.N.Medical college jodhpur Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414127101 |
| Fax |
|
| Email |
ajitsinghbaghela@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior Professor |
| Affiliation |
Dr. S.N.Medical college jodhpur |
| Address |
Department of anaesthesiology, Dr. S.N.Medical college jodhpur Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.N.Medical college Jodhpur |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology DrSNMedical college jodhpur |
| Address |
Department of anaesthesiology, Dr. S.N.Medical college jodhpur Rajasthan |
| 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 Ajit Singh Baghela |
Dr S.N.Medical college Jodhpur and associated hospitals |
Department of anaesthesiology,
MDM hospital Dr. S.N.Medical college,jodhpur
Jodhpur
RAJASTHAN |
9414127101
ajitsinghbaghela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Giving inj. Metoclopramide 10mg 2 hours before surgery |
Ultrasound assessment of gastric volume done after 30 minutes after injection metoclopramide in patients with 2 hour of fasting after clear fluids intake |
| Intervention |
Ultrasound assessment of gastric volume after overnight fasting 2 hours prior to elective surgery |
Ultrasound assessment of gastric volume after overnight fasting hours prior to elective surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 And ASA 2 patients undergoing elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients refusal, patients with GERD , pregnant patients. |
|
|
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 |
| To assess the gastric volume and contents using ultrasonography in patients, after overnight fasting and after 2 hours of fasting prior to surgery |
To assess the gastric volume and contents using ultrasonography in patients, after overnight fasting and after 2 hours of fasting prior to surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding the risk of perioperative pulmonary aspiration and incidence of dehydration and hypoglycemia from prolonged fasting. |
2 hours post surgery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Post graduation thesis not published yet but planned in future |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aspiration of gastric contents is a serious perioperative event associated with morbidity and mortality. Direct assessment of gastric volume via ultrasound gives us exact idea of gastric volume and contents . This can help us reducing the fasting period of the patients which is very uncomfortable. The purpose of this study is whether we can reduce the fasting period with use of ultrasound and administration of injection metoclopramide. |