| CTRI Number |
CTRI/2017/08/009290 [Registered on: 08/08/2017] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Gastric Volume Measurement Using Ultrasonography With and Without Acid Aspiration Premedication. |
|
Scientific Title of Study
|
Comparison Of Ultrasonographic Measurement Of Gastric Antral Volume and pH With And Without Pharmacological Acid Aspiration Prophylaxis-Randomised Clinical 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 Ashok Shankar Badhe |
| Designation |
Senior Professor |
| Affiliation |
JIPMER |
| Address |
Department Of Anesthesiology And Critical care
JIPMER
Pondicherry
35,SECTION A QUARTERS,
JIPMER CAMPUS
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894436714 |
| Fax |
|
| Email |
ashok1956badhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P SAKTHIRAJAN |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department Of Anesthesiology And Critical care
JIPMER
Pondicherry
Department Of Anesthesiology And Critical care
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KBalaji |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department Of Anesthesiology And Critical care
JIPMER
Pondicherry
Department Of Anesthesiology And Critical care
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
60506
India |
| Phone |
9578264098 |
| Fax |
|
| Email |
balalak.raj@gmail.com |
|
|
Source of Monetary or Material Support
|
| intra Mural Fund Grant Committee,
JIPMER,
PONDICHERRY |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER,PONDICHERRY |
| 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 |
| DRASHOK SHANKAR BADHE |
JIPMER |
department of anesthesiology and critical care,
PONDICHERRY
Pondicherry
PONDICHERRY |
9894436714
ashok1956badhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTE ETHICS COMMITTEE(HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
all ASA 1 and ASA 2 patients posted for elective surgeries under general anesthesia in jipmer, (1) ICD-10 Condition: Z408||Encounter for other prophylactic surgery, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet.Famotidine 20mg PO
Tablet.metoclopromide 10 mg PO |
Group NP patients will not receive any acid aspiration premedication apart from routine anxiolytics. |
| Intervention |
Tablet.Famotidine 20mg PO
Tablet.Metoclopromide 10mg PO |
group P patients will receive premedication(famotidine 20mg PO) night the day before surgery,and onthe day of surgery(Famotidine 20mg and Metoclopromide 10 mg PO) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 patients posted for elective surgeries |
|
| ExclusionCriteria |
| Details |
1.obstetric and puerperal surgeries
2.obese patient BMI>35
3.surgeries under regional anesthesia
4.previous history of GERD hiatal hernia acid peptic disease,
5.history of diabetic autonomic neuropathy
6.past history of Gastro intesinal surgeries
7.patient already in continuous nasogastric drainage |
|
|
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 and pH not going to increase to critical level for risk of aspiration by avoidance of famotidine and metoclopromide |
gastric volume and pH not going to increase to critical level for risk of aspiration by avoidance of famotidine and metoclopromide |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ULTRASONOGRAPHY is more reliable to assess gastric volume status |
80% sensitivity compared to conventional naso gastric tube method |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2017 |
| Date of Study Completion (India) |
30/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Permission will be obtained from the institute ethics committee. Patients satisfying the inclusion criteria will be enrolled for the study. Informed consent will be obtained from all patients by explaining study procedure in their own language. The patients will be randomly assigned into two groups (115 patients each) on previous day of surgery. Premedication with tab. diazepam (0.1mg/kg) for preoperative anxiolysis will be provided on night before the day of surgery and on morning of the surgery. Regular medication for chronic illness will be continued according to their necessity. Both group patients will be instructed regarding fasting guidelines. All patients will be kept for 8 hours fasting after full meal with high calorie or fat content, 6 hours after a light meal, 2-4 hrs for clear liquid. Group P patients will receive tab. famotidine 20mg on night before surgery and tab. metoclopromide 10mg along with tab. famotidine 20mg on 2 hrs before surgery. Group NP patients will not receive any acid aspiration premedication. Observer will be blinded in this study. Preoperative instructions will not available for the person who doing USG and NG tube aspiration. Once both patients entered their respective OT, patient will be wheeled inside preoperative holding area in operation theatre. Once patient privacy ensured, patient will be examined by using curvilinear 2-5MHz probe. Probe will be placed in parasagittal section over oblique left upper quadrant plane of the abdomen in supine posture. Gastric antrum will be located between left lobe of liver and superior mesenteric artery.once antrum location confirmed ,status of antrum will be assessed.it will be graded as grade I (closed) or grade II (open). If gastric antrum status is grade II, then its anteroposterior(AP) diameter and cranio caudal(CC) diameter will be measured in millimeter.Same will be repeated after change the posture of the patient to right lateral and semi sitting position. From these diameter gastric antral CSA will be calculated and gastric volume will be derived. Induction and airway management for the patient will be decided by attending anaesthesiologist of that patient. Then after induction of GA, appropriate size nasal /oral gastric tube will be used for naso/oro gastric tube placement. Position of nasal/oral gastric tube will be confirmed by injection of 5cc air and auscultation over epigastric region by stethoscope. Once position confirmed, 50ml syringe will be used for aspirating gastric contents in four different positions such as supine posture, right lateral position (30degree), left lateral position (30degree) and head down at 30degrees. Then 1ml of gastric aspirate will be used for measuring gastric pH by using digital pH meter. The amount of gastric volume aspirated will be noted. Then nasogastric tube will be removed or kept depending upon surgeons need. Parameters to be studied:1) Measuring gastric antral cross sectional area;
Gastric antral CSA will be
calculated from antral antero posterior(AP) diameter and cranio caudal (CC)
diameter by following formula(1). Both AP and CC diameter will be measured in
preoperative holding area before induction.
CSA=
(AP× CC× π) ÷ 4
2)
Measuring gastric volume:
Gastric volume measured from
antral CSA by following formula
GV (ml) =
27.0 + 14.6 × right-lat CSA ˗˗1.28× Age
3)
Gastric aspiration volume
measurement by conventional naso/oro gastric tube aspiration.
4)
pH of gastric aspirate by pH
monitor.
5)
Number of patient receiving rescue
medication before induction.
6)
post operative follow up for
respiratory signs and symptoms. RESCUE MEDICATION During USG based gastric volume measurement, if gastric volume of the patient found to be more than 1.5ml/kg patient will receive intravenous metoclopromide 10mg before induction, irrespective of previous aspiration prophylaxis status and rapid sequence induction with cricoid pressure will be done in those patients. |