Can sedation using a combination of propofol and dexmedetomidine enhance the satisfaction of the endoscopist in endoscopic submucosal dissection?

Abstract

Background and study aims The aim of this pilot randomized controlled trial was to evaluate and compare the satisfaction of the endoscopist along with the effectiveness and safety of sedation between sedation protocol using a combination of propofol (PF) and dexmedetomidine (DEX) (Combination group) and sedation protocol using PF alone (PF group) during gastric endoscopic submucosal dissection (ESD). Patients and methods Fifty-eight patients with gastric neoplasias scheduled for gastric ESD were enrolled and randomly assigned to the two groups. The satisfaction scores of the endoscopists and the parameters for the effectiveness and safety of sedation were evaluated by comparisons between the two groups. Results The satisfaction scores of the endoscopists, which were measured using a visual analogue scale, were significantly higher in the Combination group than in the PF group (88 vs. 69, P = 0.003). The maintenance dose of PF was lower in the Combination group than in the PF group (2 mg/kg/h vs. 5 mg/kg/h, P < 0.001), and the number of rescue PF injections was fewer in the Combination group than in the PF group (2 times vs. 6 times, P < 0.001). The incidence of bradycardia (defined as a pulse rate ≤ 45 bpm) in the Combination group was higher than that in the PF group (37.9 % vs. 10.3 %, P = 0.029). Conclusions This study suggests that gastroenterologist-directed sedation using a combination of PF and DEX during gastric ESD can enhance the satisfaction levels of endoscopists by providing stable sedation with an acceptable safety profile.

Comparison of two supplemental oxygen methods during gastroscopy with propofol mono-sedation in patients with a normal body mass index

“…These factors might be attributed to the same satisfaction of patients in the two groups. And (3) Multiple attempts at gastroscope insertion by significant body movement and interruption of endoscopy by urgent airway management were the main reasons for the dissatisfaction of physicians[ 30 , 31 ]. As an initial deep sedation was routinely used in our practice, all body movements observed in this study were slight and did not affect the gastroscope insertion procedure.…”

Guidelines for sedation in gastroenterological endoscopy (second edition)

“…Side effects influencing circulatory dynamics (e.g., bradycardia, hypotension) can occur due to sympathetic nerve blocking effects, 9 and dexmedetomidine hydrochloride‐administered groups were shown to have a higher frequency of hypotension and bradycardia during ERCP and esophageal/gastric ESD; hence, sufficient care must be given to circulatory dynamics during drug administration 2,10,11 . The administration method is also somewhat complicated, requiring a 10 min initial loading period; furthermore, single drug administration can destabilize circulatory dynamics, 12 and it has a higher cost than other drugs.…”

Efficacy of sedation with dexmedetomidine plus propofol during esophageal endoscopic submucosal dissection

“…In previous ESD sedation trials, we had performed retrospective studies on the feasibility and safety of sedation performed using PF plus DEX. 16,17 However, to the best of our knowledge, a prospective double-blind randomized controlled trial had not yet been performed on the PF plus DEX combination for sedation during esophageal ESD, and this is the first such study to report the efficacy of this sedation method.…”

“…For sample size estimation, we assumed that the incidence of restlessness of the patients would be 3% in the combination group and 33% in the PF group on the basis of previous studies. 12,16 To detect the decrease in the incidence of restlessness in the combination group with a two-sided significance level of 5% and 80% power, we ascertained that a sample size of 32 patients per group was required. With the assumption of a 10% dropout rate, we proposed to recruit 36 patients per group (72 patients in total).…”