scholarly journals Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiaoqiang Zhang ◽  
Shuang Li ◽  
Jing Liu
Keyword(s):  
Adverse Events ◽  
Study Protocol ◽  
Controlled Trial ◽  
Incidence Rates ◽  
Injection Pain ◽  
Efficacy And Safety ◽  
Low Oxygen ◽  
Link Type ◽  
Recovery Times ◽  
Infusion System

Abstract Background Remimazolam besylate is a newer benzodiazepine with characteristics of quick onset of effects, short maintenance and recovery times without accumulation in tissues. This trial was conducted to confirm the efficacy and safety of remimazolam besylate versus propofol during hysteroscopy. Methods Patients undergoing hysteroscopy were randomly assigned to either the remimazolam (Group R) or the propofol group (Group P). Group R was administered an induction dose of 0.2 mg/kg and a maintenance dosage of 1.0 mg/kg/h. In Group P, propofol was started at 1.5–2.0 mg/kg and then maintained at 3.0–6.0 mg/kg/h. After remimazolam besylate or propofol induction, remifentanil was infused using a target-controlled infusion system with a target concentration of 1.5 ng/ml and titrated during the procedure. The incidence rates of injection pain, low oxygen saturation (SpO2) and adverse effects in both groups were compared. Results Eighty-two patients were included in this study. The incidence of adverse events in Group R (3.7%) was significantly lower than that in Group P (36.6%) (p < 0.001). The incidence of injection pain in Group P (80.5%) was much higher than that in Group R (2.4%) (p < 0.001). The incidence of other adverse events, such as low SpO2, bradycardia, and hypotension in Group R was lower than that in Group P (p < 0.05). Conclusions Remimazolam besylate proves to be a safer alternative for anesthesia during hysteroscopy. Moreover, adverse events caused by propofol, such as low SpO2 and injection pain, are largely avoided. Trial registration This study was approved by the Clinical Research Ethics Committee of Mengcheng County No. 1 People’s Hospital (2020MYL20003) and registered at http://www.chictr.org.cn (15/09/2020, ChiCTR-2000038252). The study protocol followed the CONSORT guidelines. The study protocol was performed in the relevant guidelines.

scholarly journals Efficacy and Safety of Remimazolam Besylate Versus Propofol during Hysteroscopy: Single‐centre Randomized Controlled Trial

2021 ◽  
Author(s):  
Xiaoqiang Zhang ◽  
Shuang Li ◽  
Jing Liu
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Body Movement ◽  
Incidence Rates ◽  
Injection Pain ◽  
Efficacy And Safety ◽  
Quality Of Recovery ◽  
Recovery Times ◽  
New Type

Abstract Background: Remimazolam besylate is a new type of benzodiazepine that has the characteristics of quick effects, short maintenance and recovery times, and no accumulation. Compound opioids can have a sedative effect in some endoscopic examinations. This trial was conducted to confirm the efficacy and safety of remimazolam besylate versus propofol during hysteroscopy.Methods: Patients undergoing hysteroscopy were randomly assigned to either the remimazolam (Group R, n=41) or the propofol group (Group P, n=41). Group R was administered an induction dosage of 0.2 mg/kg/min and a maintenance dosage of 1 mg/kg/h. Group P was started at 1.5-2.0 mg/kg propofol for up to 60-100 s and then maintained at 3.0-6.0 mg/kg/h. In both groups, remifentanil was infused using a target-controlled infusion system with a target concentration of 1.5 ng/ml and titrated during the procedure. The incidence rates of body movement and various adverse events in both groups were compared.Results: Eighty-two patients were included in this study. The incidence of adverse events in Group R (8.5%) was significantly lower than that in Group P (36.6%) (P < 0.05). Injection pain, postoperative dizziness and low SpO2 were the most common adverse events (P < 0.05). Compared with Group P patients, Group R patients recovered faster, had a shorter residence time in the PACU, and exhibited a higher quality of recovery (P < 0.05).Conclusion: Remimazolam besylate can provide safe and effective sedation for hysteroscopy. The depth of sedation is sufficient and effective, and the quality of recovery is high. Moreover, adverse events such as haemodynamic fluctuation, excessive sedation depth, low SpO2 and injection pain caused by propofol are largely avoided.Trial registrationThis study was approved by the Clinical Research Ethics Committee of Mengcheng County No.1 People's Hospital (2020MYL20003) and registered at http:// www.chictr.org.cn (15/09/2020, ChiCTR-2000038252). The study protocol is performed in the relevant guidelines.

scholarly journals Efficacy and safety associated with the infusion speed of intravenous immunoglobulin for the treatment of Kawasaki disease: a randomized controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Saori Fukui ◽  
Mitsuru Seki ◽  
Takaomi Minami ◽  
Kazuhiko Kotani ◽  
Kensuke Oka ◽  
...  
Keyword(s):  
Kawasaki Disease ◽  
Adverse Events ◽  
Intravenous Immunoglobulin ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Link Type ◽  
Cell Counts ◽  
Infusion Speed ◽  
Ivig Administration

Abstract Background High-dose intravenous immunoglobulin (IVIG) is the mainstay of treatment for Kawasaki disease (KD). Usually, 2 g/kg of IVIG is administered over 10–24 h, depending on the institution or physician, but the association between infusion speed and effectiveness has not been reported. In this study, we evaluated the differences in efficacy and safety between two different IVIG administration speeds. Methods This was a multicenter, unblinded, randomized controlled study. Patients newly diagnosed with KD were randomized into two groups: one who received IVIG over 12 h (12H group, double speed), and one that received IVIG over 24 h (24H group, reference speed). The endpoints included the duration of fever, incidence of coronary artery abnormalities (CAAs) and of adverse events. Laboratory data were evaluated before and after IVIG administration. Results A total of 39 patients were enrolled. There was no difference between groups in fever duration after the initiation of IVIG (21 h vs. 21.5 h, p = 0.325), and no patient experienced CAAs. Two adverse events were observed in the 12H group (elevation of aspartate aminotransferase and vomiting), however no severe adverse events requiring treatments or extension of hospital stay were observed in either group. After initial IVIG administration, the change ratio of inflammatory markers, such as white blood cell counts, neutrophils, C-reactive protein, and albumin, did not show significant differences between the two groups. On the other hand, a greater increase of serum immunoglobulin G from its baseline level was observed in the 24H group compared to the 12H group (3037 ± 648 mg/dl vs. 2414 ± 248 mg/dl, p < 0.01). Conclusion The efficacy and safety of IVIG administered over 12 h (double speed) were similar to those administered over 24 h (reference speed). Trial registration University Hospital Medical Information Network (UMIN000014665). Registered 27 July 2014 – Prospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017058

scholarly journals Efficacy and Safety of Bushenjiangya-Optimized Granule for Left Ventricular Diastolic Dysfunction in Hypertensive Patients: A Double-Blind, Randomized, Placebo-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Qun Gao ◽  
Xiao-yun Cui ◽  
Fei Dong ◽  
Wen-ying Fan ◽  
Pin-hui Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Diastolic Dysfunction ◽  
Controlled Trial ◽  
Left Ventricular Diastolic Dysfunction ◽  
Left Ventricular ◽  
Major Adverse Cardiovascular Events ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Effective Response ◽  
Ventricular Diastolic Dysfunction

Objective. The study aimed to evaluate the efficacy and safety of Bushenjiangya-optimized (BSJYO) granule on left ventricular diastolic dysfunction (LVDD) in hypertensive (HTN) patients. Methods. 120 patients diagnosed with HTN plus LVDD were randomly assigned to the BSJYO granule group and placebo group, and all patients received basal western medicine (WM) treatment. After eight weeks of treatment, we evaluated echocardiography, traditional Chinese medicine (TCM) syndromes, 24-hour ambulatory blood pressure, liver and kidney functions, and adverse events. Major adverse cardiovascular events (MACEs) were collected at 6-month follow-up. Results. Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P<0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P<0.01). There were no differences between treatment groups in kidney and liver function, early adverse events, or MACE. Conclusion. BSJYO granule plus basal WM is an effective and safe therapy for HTN patients with LVDD.

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