Efficacy and Safety of the Remimazolam-Alfentanil Combination for Sedation During Gastroscopy: A Randomized, Double-blind, Single-center Controlled Trial.

PURPOSE: Propofol infusion is a popular single drug of choice for sedation in the gastrointestinal endoscopy suite. Drug combinations are more beneficial than single-drug regimens in gastroscopy sedation. However, the cardiopulmonary complications of propofol sedation raise concern. Remimazolam is a novel, ultra-short-acting benzodiazepine sedative, and alfentanil is a weak opioid. During endoscopic procedures, remimazolam is an effective and safe sedative procedure. No synergistic effect has been reported when remimazolam was combined with alfentanil in gastroscopy sedation. Here, we evaluated the effective dose, sedative efficacy, and safety of the remimazolam-alfentanil combination in gastroscopy sedation and compared the results with those of the propofol-alfentanil combination. METHODS: This study was conducted in two parts. In Part 1, Dixon's up-and-down method (sequential distribution) was adopted for determining the 95% effective dose (ED95) (95% CI) and 95% CI of remimazolam combined with 5 µg/kg alfentanil. In Part 2, after obtaining the predictive remimazolam ED95, 161 patients were randomized into the remimazolam group (remimazolam-alfentanil) and the propofol group (propofol-alfentanil). The effectiveness of the drug combinations was measured according to successful sedation parameters. Changes in vital signs and the appearance of adverse events were used to assess the safety of drug combinations. Evaluation of patient and physician satisfaction was included as quality indicators of treatment. RESULTS: Baseline demographic and clinical characteristics were comparable between the 2 parts of the study. The ED95 of remimazolam in inhibiting a positive response to gastroscopy placement into the pharyngeal cavity was 0.33 mg/kg (95% CI, 0.289 to 1.023). The procedure success rate was 97.53% in the remimazolam group and 97.50% in the propofol group. The difference in the success rate of the procedure between the remimazolam and propofol groups was 0.03% (95% CI, -2.5 to 2.4). However, the incidence of injection pain, hypotension, respiratory depression, and dizziness was lower in the remimazolam group compared with the propofol group (P < 0.05). Furthermore, patients from the propofol group were more likely to be drowsy, and their work efficiency was reduced the day after leaving the hospital, whereas patients in the remimazolam group were less affected (P < 0.05). IMPLICATIONS: The ED95 of remimazolam was 0.33 mg/kg when it was combined with alfentanil (5 µg/kg) for gastroscopy sedation. The sedation strategy of remimazolam-alfentanil has noninferior efficacy, fewer adverse effects, and a better postoperative recovery process than propofol-alfentanil for patients undergoing gastroscopy. Chinese Clinical Trials Registry identifier: ChiCTR2100051565.

EUS in the diagnosis of pathologically undiagnosed esophageal tuberculosis.

BACKGROUND: Esophageal tuberculosis (ET) is relatively rare, and the diagnosis is challenging. The aim of this study was to evaluate the clinical features of ET and highlight the role of endoscopic ultrasonography (EUS) in the diagnosis of pathologically undiagnosed ET. METHODS: We retrospectively analysed the clinical features, radiological performances, conventional endoscopic appearances, EUS features, treatment and outcomes of pathologically undiagnosed ET between January 2011 and December 2018. All 9 patients failed to be diagnosed by at least two repeated biopsies (such as routine biopsy, multipoint or deep biopsy, and even or EUS-guided fine-needle aspiration (EUS-FNA)). RESULTS: Nine patients (66.7% female) with a mean age of 45 years (range 29-59) complained of retrosternal pain or discomfort, or (and) dysphagia. Esophagoscopy demonstrated protruding lesions in the mucosa with central ulcers or erosion in five patients, submucosal bulges with smooth surfaces in one patient, submucosal bulges with diverticula in one patient, ulcers with suspicious fistula formation in one patient, and multiple ulcers in one patient. None of the patients received confirmed histopathological or bacteriological diagnoses by repeated biopsies. However, they were first suspected to have ET based on EUS examination. Because EUS found some characteristic ultrasonographic changes, which were very helpful for the diagnosis of ET when combined with clinical manifestations, the patients subsequently received diagnostic antituberculosis therapy. Finally, the patients recovered or improved with follow-up times ranging from 3 to 10 months. CONCLUSIONS: EUS could help in the diagnosis of ET on basis of EUS features like poorly defined esophageal wall structure, enlarged paraesophageal or mediastinal lymph nodes, hypoechoic lesions of esophageal wall that are linked to the enlarged paraesophageal lymph nodes. However all attempts should be made to obtain histological or microbiological diagnosis.