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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03438305
• Collaborator: (none)
• Enrollment: 48
• Anticipated Duration (Months): 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Other: sonar assessment of gastric volume in Diabetic patients; Other: sonar assessment of gastric volume in Non Diabetic patients

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 48 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).
• Anticipated Study Start Date: Mar 1, 2018
• Anticipated Primary Completion Date: Jun 1, 2018
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group D	Other: sonar assessment of gastric volume in Diabetic patients; assessment of gastric volume in Diabetic Patients
Group N	Other: sonar assessment of gastric volume in Non Diabetic patients; assessment of gastric volume in Non- Diabetic Patients

Outcome Measures

Primary Outcome Measures

1. assessment of residual gastric volume in longstanding diabetic patients [intra-operative]

   To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients

Secondary Outcome Measures

1. correlation between preoperative gastric US findings and fasting hours in both groups [intraoperative]

   To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherin Refaat, Lecturer of Anesthiology, Cairo University
• ClinicalTrials.gov Identifier: NCT03438305
• Other Study ID Numbers: N-74-2017
• First Posted: Feb 19, 2018
• Last Update Posted: Feb 19, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroparesis

Study Results

No Results Posted as of Feb 19, 2018