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Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for oesophageal varices: a study protocol for prospective interventional study

Abstract

Background Dexmedetomidine (DEX) is a novel, highly selective α2-adrenoceptor agonist that elicits sedative, amnestic, sympatholytic and analgesic effects in patients. Several Japanese investigators have reported the clinical usefulness of DEX for sedation in endoscopic therapies for gastrointestinal malignancies; however, there have been limited data regarding the usefulness and safety of DEX for sedation during endoscopic procedures for oesophageal varices (OVs), such as endoscopic injection sclerotherapy (EIS). In this prospective, single-arm interventional study, we aimed to elucidate these issues.

Methods Patients who require two or more sessions of prophylactic EIS for the treatment of OVs will be enrolled in this prospective interventional study. EIS procedures include two methods: (1) sedation during endoscopic procedures will be performed using conventional methods (pentazocine (PNZ) and midazolam (MDZ)), and (2) sedation during endoscopic procedures will be performed using PNZ, low-dose MDZ and DEX. These two methods were randomly assigned in the first and second EIS. The effect and safety of these two procedures with respect to patient sedation are to be compared with the degree of sedation evaluated using the Bispectral Index monitoring system (Aspect Medical Systems, Norwood, Massachusetts, USA).

Ethics and dissemination This study received approval from the Institutional Review Board at Hyogo College of Medicine (approval no. 2324). The authors are committed to publishing the study results as widely as possible in peer-reviewed journals, and to ensuring that appropriate recognition is provided to everyone who is working on this study.

Trial registration number UMIN000026688; Pre-results.

  • ENDOSCOPIC PROCEDURES
  • CIRRHOSIS
  • GASTROINTESINAL ENDOSCOPY
  • OESOPHAGEAL VARICES

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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