RT Journal Article
SR Electronic
T1 Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for oesophageal varices: a study protocol for prospective interventional study
JF BMJ Open Gastroenterology
FD BMJ Publishing Group Ltd
SP e000149
DO 10.1136/bmjgast-2017-000149
VO 4
IS 1
A1 Hiroki Nishikawa
A1 Yoshinori Iwata
A1 Akio Ishii
A1 Hirayuki Enomoto
A1 Yukihisa Yuri
A1 Noriko Ishii
A1 Yuho Miyamoto
A1 Kunihiro Hasegawa
A1 Chikage Nakano
A1 Ryo Takata
A1 Takashi Nishimura
A1 Kazunori Yoh
A1 Nobuhiro Aizawa
A1 Yoshiyuki Sakai
A1 Naoto Ikeda
A1 Tomoyuki Takashima
A1 Hiroko Iijima
A1 Shuhei Nishiguchi
YR 2017
UL http://bmjopengastro.bmj.com//content/4/1/e000149.abstract
AB 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.