COMPARISON OF STOMACH CONTENTS IN DIABETIC AND NORMAL PATIENTS USING ULTRASOUND

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2015/08/006129
• Lead Sponsor: POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

Brief Summary

Pulmonary aspiration of gastric contents is a grave perioperative complication which can lead to significant morbidity and mortality. Delayed gastric emptying, also called gastroparesis, is a common occurrence in patients with diabetes mellitus. Since diabetics are prone to have a gastroparetic state, these patients are put under a category of high-risk patients for peri-operative risk of pulmonary aspiration. A rapid sequence induction (RSI) is the preferred technique for such patients. A study has refuted the role of RSI asserting that both the diabetics and non-diabetics have similar volumes of gastric content. But the study has mainly been done post-intubation and by assessing the manual gastric aspirate. There is a growing interest in the use of bedside ultrasonography (USG) to assess gastric content and volume. It has been suggested that the gastric antrum can be assessed reliably by sonography. Since USG is widely available and a reliable bedside method to assess the gastric contents, it can be readily used for assessing the difference between non-diabetic patients and patients with DM posted for surgery prior to induction and see if a real time difference exists or not. Therefore, the present study is planned to compare the fasting gastric volume in diabetic and non-diabetic patients undergoing elective surgery under general or regional anaesthesia by means of preoperative ultrasound.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Last Update Posted: 2019-04-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• •Study group.
• Patients with diagnosed type 1 or type 2 DM on either oral hypoglycaemics or insulin therapy •Control group.
• Non-diabetic patients with fasting blood sugar (FBS) levels of less than 100 mg/dl or random blood sugar (RBS) levels of less than 140 mg/dl. For both groups, the standard inclusion criteria will be : •Age more than 18 years. •ASA grade I-III. •Patients posted for elective surgery before noon.

Exclusion Criteria

• •Patients on medication for upper GIT symptoms.
• •Patients having hypothyroidism or connective tissue disease affecting GIT motility.
• •Patients with smoking history.
• •Patients on anti-depressant medication.
• •Previous oesophageal or abdominal surgery leading to impaired GIT function.
• •Patients having impaired fasting glucose or RBS levels between 140-199 mg/dl (pre-diabetes).
• •Morbidly obese patients with a body mass index (BMI) of more than 40.
• •Pregnant females.
• .patients with nasogstric tube in situ.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of the study is to compare the fasting gastric contents and volume using ultrasound in diabetic and non-diabetic patients undergoing elective surgery under general or regional anaesthesia	Patients taken up for surgery before noon prior to provision of anaesthesia .

Secondary Outcome Measures

Name	Time	Method
The secondary aim is to validate the use of ultrasound as a non invasive bedside method to assess the gastric fluid volume.	Patients taken up for surgery before noon prior to provision of anaesthesia.

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

DR HEENA GARG

Principal investigator

9464533877

GARGHEENA11@GMAIL.COM