Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.

Gastroparesis Clinical Trial

Official title:

Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03438305
• Other study ID #: N-74-2017
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2018
• Last updated: February 16, 2018
• Start date: March 1, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume >1.5 ml/kg) during the preoperative period in longstanding diabetic patients.

Study population :

• -Longstanding diabetic patients (group D)

• -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.

Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups.

Second set of analysis will be finding correlation between US findings and suction volume in two groups.

Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients.

Sample Size ; was calculated as 48 patients (24) in each group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Ages from 40 to 60 years old.

• American Society of Anesthiologist (ASA) II.

• Diabetic patients with longstanding duration(more than 6 years).

Exclusion Criteria:

• Age <40,>60 years .

• Pregnant female

• Obese patients (BMI =40)

• Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.

• Diabetic patients less than 6 years.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Other:
• sonar assessment of gastric volume in Diabetic patients
assessment of gastric volume in Diabetic Patients
• sonar assessment of gastric volume in Non Diabetic patients
assessment of gastric volume in Non- Diabetic Patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of residual gastric volume in longstanding diabetic patients	To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients	intra-operative
Secondary	correlation between preoperative gastric US findings and fasting hours in both groups	To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group.	intraoperative