Comparison Of Gastric Volume Measurement Using Ultrasonography With and Without Acid Aspiration Premedication.

Phase 3

Completed

• Conditions: Encounter for other prophylactic surgery,

• Registration Number: CTRI/2017/08/009290
• Lead Sponsor: JIPMER

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 becalculated from antral antero posterior(AP) diameter and cranio caudal (CC)diameter by following formula(1). Both AP and CC diameter will be measured inpreoperative holding area before induction.

CSA=(AP× CC× Ï€)   ÷   4

2)   Measuring gastric volume:

Gastric volume measured fromantral CSA by following formula

GV (ml) =27.0 + 14.6 × right-lat CSA ˗˗1.28× Age

3)   Gastric aspiration volumemeasurement by conventional naso/oro gastric tube aspiration.

4)   pH of gastric aspirate by pHmonitor.

5)   Number of patient receiving rescuemedication before induction.

6)   post operative follow up forrespiratory 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-10
• Study Completion: 2018-05-30
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

ASA 1 and ASA 2 patients posted for elective surgeries.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
ULTRASONOGRAPHY is more reliable to assess gastric volume status	80% sensitivity compared to conventional naso gastric tube method

Trial Locations

Locations (1)

JIPMER; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER

🇮🇳Pondicherry, PONDICHERRY, India

DRASHOK SHANKAR BADHE

Principal investigator

9894436714

ashok1956badhe@gmail.com