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Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial.

ABSTRACT: Upper gastrointestinal endoscopy has been performed after fasting 8 or more hours, which can be harmful to the patients. We assessed comfort, safety and quality of endoscopy under moderate sedation after 2 hours fasting for clear liquids.In this clinical trial, patients referred for elective endoscopy were randomly assigned to a fasting period of 8 hours (F8) or a shorter fasting (F2), in which 200 ml of clear liquids were ingested 2 hours before the procedure. Endoscopists blinded to patients fasting status carried out the endoscopies. Comfort was rated by the patients, whereas safety and quality were determined by the endoscopists.Ninety-eight patients were studied (aging 48.5 ± 16.5 years, 60% women): 50 patients (51%) in F2 and 48 in F8. Comfort was higher in F2 than F8 in regard to anxiety (8% vs. 25%; P = 0.029), general discomfort (18% vs. 42%; P = 0.010), hunger (44% vs. 67%; P = 0.024), and weakness (22% vs. 42%; P = 0.034). Regurgitation of gastric contents into the esophagus after endoscopic intubation did not differ between F2 and F8 (26% vs. 19%; P = 0.471). There was no case of pulmonary aspiration. Gastric mucosal visibility was normal in most patients either in F2 or F8 (96% vs. 98%; P = 0.999).Elective upper GI endoscopy after 2 hours fasting for clear liquids was more comfortable and equally safe compared to conventional fasting. This preparation might be cautiously applied for patients in regular clinical conditions referred for elective endoscopy.SAMMPRIS ClinicalTrial.gov number, NCT01492296.

SUBMITTER: Koeppe AT

PROVIDER: S-EPMC4225862 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial.

Koeppe Angélica Terezinha AT Lubini Marcio M Bonadeo Nilton Maiolini NM Moraes Iran I Fornari Fernando F

BMC gastroenterology 20131109

<h4>Background</h4>Upper gastrointestinal endoscopy has been performed after fasting 8 or more hours, which can be harmful to the patients. We assessed comfort, safety and quality of endoscopy under moderate sedation after 2 hours fasting for clear liquids.<h4>Methods</h4>In this clinical trial, patients referred for elective endoscopy were randomly assigned to a fasting period of 8 hours (F8) or a shorter fasting (F2), in which 200 ml of clear liquids were ingested 2 hours before the procedure. ...[more]

PMID: 24209639

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Project description:BackgroundGastrointestinal endoscopy has been associated with difficult experiences and can leave patients with an unpleasant impression. Propofol and midazolam are the most commonly used intravenous anesthetics for sedation during gastrointestinal endoscopy. However, cardiac and pulmonary adverse events are the primary concerns associated with the use of these sedatives. Remimazolam tosylate is an ultra-short-acting benzodiazepine drug with a mild inhibitory effect on the respiratory and circulatory systems. These properties qualify remimazolam tosylate to be used as a replacement for propofol or midazolam as a sedative during gastrointestinal endoscopy. This study aims to describe the efficacy and safety of remimazolam tosylate as a sedative for upper gastrointestinal endoscopy.MethodsA multicenter, randomized, single-blind, parallel-controlled, noninferiority clinical study will be conducted to evaluate the efficacy and safety of remimazolam tosylate as a sedative during upper gastrointestinal endoscopy. Participants (n = 1800) will be randomized to receive remimazolam tosylate at 0.15 mg/kg (experimental group 1), remimazolam tosylate at 0.2 mg/kg (experimental group 2), or propofol at 1.5 mg/kg (control group). Procedure success will be assessed and defined as the completion of upper gastrointestinal endoscopy without the administration of a rescue sedative agent or more than two top-up doses of the trial drug in any 5-min period after initial administration. Sedation quality will be evaluated using the Modified Observer's Assessment of Alertness/Sedation score. Adverse events will be recorded to evaluate safety.DiscussionThis study will determine the optimal dosage of remimazolam tosylate during upper gastrointestinal endoscopy and will describe its efficacy and safety. These findings may contribute to a more comfortable and safer experience for patients compared with that when the conventional sedative propofol is used.Trial registrationClinicalTrials.gov NCT04727034. Registered on February 18, 2021.

Project description:BackgroundThe quality of gastrointestinal (GI) endoscopy has been recently identified as a major priority being associated with many outcomes and patient's experience.ObjectiveTo assess adherence of endoscopists to the European Society of Gastrointestinal Endoscopy (ESGE) quality performance measures for upper and lower GI endoscopy in Italy.MethodsAll endoscopist members of the Italian Society of Digestive Endoscopy (SIED) were invited from October 2018 to December 2018 to participate to a self-administered questionnaire-based survey. The questionnaire included questions on demographics and professional characteristics, and the recent ESGE quality performance measures for upper and lower GI endoscopy.ResultsA total of 392 endoscopists participated in the study. Only a minority (18.2%) of participants recorded the duration of esophagogastroduodenoscopy (EGD) and 51% provided accurate photo documentation in the minimum standard of 90% of cases. Almost all endoscopists correctly used Prague and Los Angeles classifications (87.8% and 98.2%, respectively), as well as Seattle and Management of precancerous conditions and lesions in the stomach (MAPS) biopsy protocols (86.5% and 91.4%, respectively). However, only 52.8% of participants monitored complications after therapeutic EGD, and 40.8% recorded patients with a diagnosis of Barrett's esophagus (BE). With regard to colonoscopy, almost all endoscopists (93.9%) used the Boston Bowel Preparation Scale for measuring bowel preparation quality and reported a cecal intubation rate ≥90%. However, about a quarter (26.2%) of participants reported an adenoma detection rate of <25%, only 52.8% applied an appropriate polypectomy technique, 48% monitored complications after the procedure, and 12.4% measured patient's experience.ConclusionThe adherence of endoscopists to ESGE performance measures for GI endoscopy is sub-optimal in Italy. There is a need to disseminate and implement performance measures and endorse educational and scientific interventions on the quality of endoscopy.

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Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial.

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Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial.

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