Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study

Abstract

Background Remimazolam tosilate (HR7056, RT), a novel ultrashort-acting benzodiazepine, can be used for procedural sedation and general anaesthesia. However, few studies have focused on the sedative effect of RT during gastrointestinal endoscopy in elderly patients. The purpose of this study is to compare the sedative effect of RT and propofol for gastrointestinal endoscopy in elderly patients. Methods A total of 82 patients aged ≥65 years with an American Society of Anaesthesiologists (ASA) grade I-II and a body mass index (BMI) of 18.0 to 30.0 kg/m2 who were scheduled for gastrointestinal endoscopy from Jan 2021 to Aug 2021 were selected and randomly divided into a RT group and a propofol group. Alfentanil 5 μg/kg was used for analgesia in both groups. The RT group was given remimazolam tosilate 0.15 mg/kg with supplemental doses of 0.05 mg/kg as need, while the propofol group was given propofol 1.5 mg/kg with supplemental doses of 0.5 mg/kg. The supplemental doses were determined by the modified observational alertness/sedation assessment (MOAA/S) score and the patients’ body movements. Sedative effects, such as the time to loss of consciousness (LOC) (MOAA/S score ≤ 1), successful sedation in one dose, number of supplemental doses after successful induction, and recovery time, were evaluated. Sedation-related side effects, such as injection pain, haemodynamic events and respiratory depression, were also noted. Postoperative nausea and vomiting (PONV), visual analogue scale (VAS) scores at rest, remedial analgesics, and dizziness or headache were recorded. In addition, patients’ satisfaction and physician’s satisfaction of the procedure were compared between the two groups. Results Data from 77 patients were analysed. The success rate of sedation in both groups was 100%. The time to LOC (MOAA/S score ≤ 1) in the RT group was longer than that in the propofol group (20.7 ± 6.1s vs. 13.2 ± 5.2s, P < 0.001). There were fewer patients in the RT group reporting injection pain than that in the propofol group (0/39 vs. 5/38, P = 0.025). Haemodynamic events and respiratory depression in the RT group were less frequent than those in the propofol group ((6/39 vs. 17/38, P = 0.005), (2/39 vs. 9/38, P = 0.026), respectively). The number of supplemental doses after successful induction in the RT group was greater than that in the propofol group (4/9/11/13/1/1 vs. 8/4/18/6/2/0 requiring 0, 1, 2, 3, 4 or 5 supplemental doses, P = 0.014). The characteristics of the patients enrolled, postoperative parameters of the patients, and patients’ and physician’s satisfaction of the procedure were comparable in the two groups. Conclusions Compared with propofol, RT can be safely and effectively used for gastrointestinal endoscopy sedation in elderly patients, and the incidence of sedation-related adverse reactions, especially haemodynamic events and respiratory depression, is lower. When RT is used, the number of supplemental doses after successful induction may increase slightly. Trial registration Chictr.org.cn ChiCTR2000040498. Retrospectively registered (date of registration: December 1, 2020).

Remimazolam Tosylate Combined with Low-Dose Propofol Improves Sedation and Safety in Hysteroscopy

“… 5 It can effectively sedate and improve the patients’ comfort, 5 , 7 but it often causes injection pain, respiratory depression, hypotension and bradycardia. 8 , 9 Remimazolam is an novel ultra-short-acting benzodiazepine. 10 It has little inhibiting effect on respiration and hemodynamics, 11 and the sedative effect of remimazolam can be rapidly reversed by flumazenil, which has a higher safety profile.…”

Efficacy and Safety of Remimazolam Mesylate in General Anesthesia Induction and Maintenance in Elderly Patients: A Single-Center, Randomized, Positive-Drug, Paralleled, Controlled Study

“…Therefore, preventing or reducing the occurrence of sedation-related complications is the best approach. The most striking nding is that although both remimazolam mesylate and propofol cause transient cardiovascular and respiratory depression, incidences of hypotension, treatment-related hypotension, and respiratory depression were lower in the remimazolam mesylate group than in the propofol group [19] and could be rapidly reversed by umazenil [20].…”

Remimazolam: An Updated Review of a New Sedative and Anaesthetic

“…The most frequently reported AEs in procedural sedation include fluctuations in BP and HR, respiratory depression, body movement, nausea or vomiting, and dizziness or headache; however, these AEs are generally mild and require no reversal treatment. 15 , 34 , 39 , 40 , 79 Remimazolam is associated with a low risk of hypotension and respiratory depression and injection site pain in procedural sedation as compared with propofol, 38 , 80 and pre-treatment with remimazolam is known to reduce the incidence and intensity of propofol-induced injection pain. 81 Furthermore, there were no significant differences in the treatment-related AEs of remimazolam and midazolam.…”

“…83 In short, remimazolam exerts little influence on the circulatory and respiratory systems with a small fluctuation range of BP and HR and causes no fatal, serious, or severe AEs during the infusion phase; moreover, remimazolam was safe and well-tolerated in all the assessed studies. 22,23,32,38,49,50,79,80,83 The use of remimazolam is recommended in combination with saline, and its use in combination with Ringer's acetate solution should be avoided because it does not completely dissolve in this solution and forms a precipitate. 84,85…”