ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03438305
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sherin Refaat, Cairo University

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
Gastroparesis Other: sonar assessment of gastric volume in Diabetic patients Other: sonar assessment of gastric volume in Non Diabetic patients

Study Type : Observational [Patient Registry]
Estimated Enrollment : 48 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort 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




Primary Outcome Measures :
  1. assessment of residual gastric volume in longstanding diabetic patients [ Time Frame: 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 [ Time Frame: intraoperative ]
    To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect gastric nerve supply.
Criteria

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.

Responsible Party: Sherin Refaat, Lecturer of Anesthiology, Cairo University
ClinicalTrials.gov Identifier: NCT03438305     History of Changes
Other Study ID Numbers: N-74-2017
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms