The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial

Liu, Xianwen; Ding, Bao-feng; Shi, Fu Dong; Zhang, Yang; Liu, Lei; Sha, Yongwei; Zhao, Tonghang

doi:10.2147/dddt.s339535

Cited by 49 publications

(64 citation statements)

References 44 publications

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“…Liu administered an initial dose of 0.15 mg/kg of remimazolam tosilate for sedation in elderly patients undergoing colonoscopy and obtained a procedural success rate of 96.52%. 17 This is consistent with our ED95 and its CIs. Moreover, results calculated using two statistical methods are similar.…”

Section: Discussionsupporting

confidence: 92%

The Median Effective Dose and Bispectral Index of Remimazolam Tosilate for Anesthesia Induction in Elderly Patients: An Up-and-Down Sequential Allocation Trial

Liu¹,

Sun²,

Zhou³

et al. 2022

CIA

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Purpose Remimazolam is a new type of ultrashort benzodiazepine drug with an unclear optimal dose for general anesthesia induction in elderly patients aged >60 years. Therefore, this study aimed to determine the effective dose of remimazolam tosilate induction and explore its correlation with the bispectral index (BIS). Patients and Methods A total of 42 elderly patients were divided into two age groups: 60–69 (group A) and 70–85 (group B) years. An initial dose of 0.1mg/kg(Group A) and 0.05 mg/kg(Group B) remimazolam tosilate was administered, and the Modified Observer’s Assessment of Alertness/Sedation scale was used to assess adequate responses. The dose was calculated using the up-and-down allocation technique based on the previous response. The sequential formula and probit regression model were used to calculate ED50 and BIS50. ED95 was determined using the probit regression model. Results The ED50 of remimazolam tosilate for anesthesia induction were 0.088 mg/kg (95% confidence interval [CI] 0.071–0.108) and 0.061 mg/kg (95% CI 0.053–0.069) in groups A and B, respectively. ED95 was 0.118 mg/kg (95% CI 0.103–0.649) and 0.090 mg/kg (95% CI 0.075–0.199) in groups A and B, respectively. The remimazolam tosilate administration could decrease BIS. BIS50 was 86.0 (95% CI 83.7–88.6) and 85.4 (95% CI 84.1–86.8) in groups A and B, respectively. Conclusion During the induction process, patients’ consciousness should be observed. The dose of remimazolam tosilate could be chosen after careful consideration of individual variations.

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Section: Discussionsupporting

confidence: 92%

The Median Effective Dose and Bispectral Index of Remimazolam Tosilate for Anesthesia Induction in Elderly Patients: An Up-and-Down Sequential Allocation Trial

Liu¹,

Sun²,

Zhou³

et al. 2022

CIA

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“…In our research, we observed that patients in remimazolam groups took less time to be fully alert than propofol group. The time to full alert in remimazolam groups was in the range of 3–10 min, which was similar to the findings in previous studies [ 20 , 28 ]. Patients also reached the standard of leaving PACU more quickly in remimazolam groups than propofol group.…”

Section: Discussionsupporting

confidence: 91%

“…Prior studies suggested the success rate of sedation was 96.52% to 97.34% for remimazolam and 100% for propofol applied in colonoscopy [ 20 , 21 , 28 ]. In our trial, propofol combined with alfentanil served as an active control.…”

Section: Methodsmentioning

confidence: 99%

Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial

et al. 2022

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Background Remimazolam is a newer benzodiazepine with properties of rapid onset, short duration of action, and fast recovery. Our study was to evaluate the effects of different doses of remimazolam combined with alfentanil in colonoscopic polypectomy. Methods One hundred twenty patients were randomly divided into four groups: alfentanil and propofol (AP) group, alfentanil and remimazolam 0.1 mg/kg (AR1 group), 0.15 mg/kg (AR2 group), or 0.2 mg/kg (AR3 group). Patients in the four groups received alfentanil 10 μg/kg, followed by propofol 2 mg/kg and three dosages of remimazolam. Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale, heart rate (HR), oxygen saturation (SpO2), respiratory rate (RR), bispectral index (BIS) values and mean arterial pressure (MAP) were collected at intervals of 5 min and analyzed at different time points: before anesthesia (T0), 5 min (T1), 10 min (T2), 15 min after anesthesia (T3) and at the end of surgery (T4). The average MAP was calculated utilizing the average of all MAP values. The primary outcome was the success rate of sedation. Secondary outcomes included time to full alert and adverse events. Results The success rate of sedation was 100% among the four groups. The incidence of hypotension was significantly decreased (all P < 0.05) and the average MAP was higher in AR1-AR3 groups than AP group (all P < 0.001). None of the patients developed bradycardia or hypertension during surgery in all study groups. BIS values were higher (all P < 0.001) and the time to full alert was statistically shorter in AR1-AR3 groups (all P < 0.05) compared with the AP group. The MOAA/S score in AR1 was higher than AR2 (P < 0.05) and the AR3 group (P < 0.05) at T1 and BIS values in the AR1 group were significantly higher than AR3 group (P < 0.05) at T4. Conclusions Remimazolam combined with alfentanil have a non-inferior sedative effect than propofol during the colonoscopic polypectomy. Moreover, this combination of two short-acting drugs might be a safer alternative. Trial registration The clinical trial was registered on (16/05/2021, ChiCTR2100046492).

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“…However, it still has some disadvantages, such as large amounts of dosage and some adverse reactions, including obvious reduction in blood pressure, bradycardia, and apnea during deep sedation [ 32 ]. Liu et al [ 33 ] pointed out that the sedative effect of remimazolam benzenesulfonate was obviously better than that of midazolam during the diagnosis and treatment by colonoscopy. The success rate of sedation by remimazolam benzenesulfonate, the dosage of sedatives, the inhibition of the circulation system, awakening time, and other parameters were all significantly superior to those of remimazolam benzenesulfonate.…”

Section: Discussionmentioning

confidence: 99%

The Clinical Application of Remimazolam Benzenesulfonate Combined with Esketamine Intravenous Anesthesia in Endoscopic Retrograde Cholangiopancreatography

2022

BioMed Research International

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In this project, algorithm-based image processing methods in 3D endoscopic image processing endoscopic retrograde cholangiopancreatography (ERCP) were analyzed. To enhance local information of images, an adaptive histogram equalization method with limited contrast is introduced. The influences of the algorithm on 3D endoscopic image peak signal-to-noise ratio (PSNR), image discrete information entropy (DE), and average mean brightness error (AMBE) of images before and after the optimization before were compared. A total of 92 patients receiving ERCP at Yuhuangding Hospital between December 2019 and December 2021 were selected and divided into the control group (fentanyl+propofol) and the observation group (remimazolam benzenesulfonate+esketamine). Mean arterial pressure heart rate (HR), oxygen saturation (SpO2), and respiratory rate (RR) of the patients at each time point including the entry into the operation room (T0), 2 minutes after the beginning of medication (T1), after endoscopy (T2), endoscopy withdrawal (T3), and postoperative awakening (T4) were recorded. The comparison of MAP between T1, T2, T3, and T4 and T0 among patients in the observation group and the control group showed statistical differences ( P < 0.05 ). Besides, HR and RR at T4 in the observation group were obviously higher than those in the control group ( P < 0.05 ). The comparison of SpO2 at T3 and T4 and that at T0 both showed statistical differences ( P < 0.05 ). Awakening time and VAS scores in the observation group were obviously lower than those in the control group ( P < 0.05 ). The incidence of bradycardia, nausea, vomiting, and chill in the observation group was all lower than that in the control group ( P < 0.05 ). The results indicated that an effective endoscopic image processing method was established based on an image enhancement algorithm, and the combination of remimazolam benzenesulfonate and esketamine showed high safety and efficacy in ERCP.

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The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial

Cited by 49 publications

References 44 publications

The Median Effective Dose and Bispectral Index of Remimazolam Tosilate for Anesthesia Induction in Elderly Patients: An Up-and-Down Sequential Allocation Trial

The Median Effective Dose and Bispectral Index of Remimazolam Tosilate for Anesthesia Induction in Elderly Patients: An Up-and-Down Sequential Allocation Trial

Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial

The Clinical Application of Remimazolam Benzenesulfonate Combined with Esketamine Intravenous Anesthesia in Endoscopic Retrograde Cholangiopancreatography

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