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NCT03438305
Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.
trial testing sonar assessment of gastric volume in Diabetic patients in Gastroparesis in 48 participants. Status unknown.
1 June 2018
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 48 |
| Start date | 1 March 2018 |
| Primary completion | 1 June 2018 |
| Estimated completion | 1 June 2018 |
Drugs / interventions tested
- sonar assessment of gastric volume in Diabetic patients
- sonar assessment of gastric volume in Non Diabetic patients
Conditions studied
- Gastroparesis — all drugs for Gastroparesis →
Sponsor
Cairo University
Who can join
Adults 40 to 60, any sex, with Gastroparesis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03438305 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 19 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03438305.
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