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      • Record: found
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      Comparison of remimazolam tosilate and propofol during induction and maintenance of general anesthesia in patients undergoing laparoscopic cholecystectomy: a prospective, single center, randomized controlled trial

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          Abstract

          Background

          Remimazolam tosilate (RT) is a new, ultrashort-acting benzodiazepine. Here, we investigated the efficacy and safety of RT for general anesthesia in patients undergoing Laparoscopic Cholecystectomy (LC).

          Methods

          In this study, 122 patients undergoing laparoscopic cholecystectomy were randomly allocated to receive either remimazolam tosilate (Group RT) or propofol group (Group P). RT was administered as a slow bolus of 0.3 mg kg − 1 for induction, followed by 1.0–2.0 mg kg − 1 h − 1 for maintenance of general anesthesia. Propofol was started at 2 mg kg − 1 and followed by 4–10 mg kg − 1 h − 1 until the end of surgery. The primary outcome was the time to bispectral index (BIS) ≤ 60. The secondary outcome included the time to loss of consciousness (LoC), and the time to extubation. Adverse events were also assessed.

          Results

          A total of 112 patients were recruited for study participation. Among them, the time to BIS ≤ 60 in Group RT was longer than that in Group P (Group RT: 89.3 ± 10.7 s; Group P: 85.9 ± 9.7 s, P > 0.05). While the time to LoC comparing remimazolam and propofol showed no statistical significance (Group RT: 74.4 ± 10.3 s; Group P: 74.7 ± 9.3 s, P > 0.05). The time to extubation in Group RT was significantly longer than that in Group P (Group RT: 16.0 ± 2.6 min; Group P: 8.8 ± 4.3 min, P < 0.001). Remimazolam tosilate had more stable hemodynamics and a lower incidence of hypotension during general anesthesia.

          Conclusions

          Remimazolam tosilate can be safely and effectively used for general anesthesia in patients undergoing Laparoscopic Cholecystectomy. It maintains stable hemodynamics during induction and maintenance of general anesthesia compared with propofol. Further studies are needed to validate the findings.

          Trial registration

          Chictr.org.cn ChiCTR2300071256 (date of registration: 09/05/2023).

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          Most cited references27

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          Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial.

          Owen T M Chan, P. MYLES, Clayton J. McNeil … (2004)
          Awareness is an uncommon complication of anaesthesia, affecting 0.1-0.2% of all surgical patients. Bispectral index (BIS) monitoring measures the depth of anaesthesia and facilitates anaesthetic titration. In this trial we determined whether BIS-guided anaesthesia reduced the incidence of awareness during surgery in adults. We did a prospective, randomised, double-blind, multicentre trial. Adult patients at high risk of awareness were randomly allocated to BIS-guided anaesthesia or routine care. Patients were assessed by a blinded observer for awareness at 2-6 h, 24-36 h, and 30 days after surgery. An independent committee, blinded to group identity, assessed every report of awareness. The primary outcome measure was confirmed awareness under anaesthesia at any time. Of 2463 eligible and consenting patients, 1225 were assigned to the BIS group and 1238 to the routine care group. There were two reports of awareness in the BIS-guided group and 11 reports in the routine care group (p=0.022). BIS-guided anaesthesia reduced the risk of awareness by 82% (95% CI 17-98%). BIS-guided anaesthesia reduces the risk of awareness in at-risk adult surgical patients undergoing relaxant general anaesthesia. With a cost of routine BIS monitoring at US16 dollars per use in Australia and a number needed to treat of 138, the cost of preventing one case of awareness in high-risk patients is about 2200 dollars.
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            Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial

            Matsuyuki Doi, Kiyoshi Morita, Junzo Takeda … (2020)
            This trial was conducted to confirm the non-inferiority of remimazolam versus propofol in the induction and maintenance of general anesthesia in surgical patients.
            Article 0 comments Cited 159 times – based on 0 reviews     Review now
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              Bispectral analysis measures sedation and memory effects of propofol, midazolam, isoflurane, and alfentanil in healthy volunteers.

              C Rosow, L Kearse, P Glass … (1997)
              The bispectral index (BIS), a value derived from the electroencephalograph (EEG), has been proposed as a measure of anesthetic effect. To establish its utility for this purpose, it is important to determine the relation among BIS, measured drug concentration, and increasing levels of sedation. This study was designed to evaluate this relation for four commonly used anesthetic drugs: propofol, midazolam, isoflurane, and alfentanil. Seventy-two consenting volunteers were studied at four institutions. Volunteers were given either isoflurane, propofol, midazolam, or alfentanil. Each volunteer was administered a dose-ranging sequence of one of the study drugs to achieve predetermined target concentrations. A frontal montage was used for continuous recording of the EEG. At each pseudo-steady-state drug concentration, a BIS score was recorded, the participant was shown either a picture or given a word to recall, an arterial blood sample was obtained for subsequent analysis of drug concentration, and the participant was evaluated for level of sedation as determined by the responsiveness portion of the observer's assessment of the alertness/ sedation scale (OAAS). An OAAS score of 2 or less was considered unconscious. The BIS (version 2.5) score was recorded in real-time and the BIS (version 3.0) was subsequently derived off-line from the recorded raw EEG data. The relation among BIS, measured drug concentration, responsiveness score, and presence or absence of recall was determined by linear and logistic regression for both the individual drugs and, when appropriate, for the pooled results. The prediction probability was also calculated. The BIS score (r = 0.883) correlated significantly better than the measured propofol concentration (r = -0.778; P < 0.05) with the responsiveness score. The BIS provided as effective correlation with responsiveness score of the OAAS as did the measured concentration for midazolam and isoflurane. None of the volunteers given alfentanil lost consciousness and thus were excluded from the pooled analysis. The pooled BIS values at which 50% and 95% of participants were unconscious were 67 and 50, respectively. The prediction probability values for BIS ranged from 0.885-0.976, indicating a very high predictive performance for correctly indicating probability of loss of consciousness. The BIS both correlated well with the level of responsiveness and provided an excellent prediction of the loss of consciousness. These results imply that BIS may be a valuable monitor of the level of sedation and loss of consciousness for propofol, midazolam, and isoflurane.
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                Author and article information

                Contributors
                Zhuxin Luo:
                ORCID: https://orcid.org/0000-0001-7872-1818
                lzx206@126.com
                Journal
                Journal ID (nlm-ta): BMC Anesthesiol
                Journal ID (iso-abbrev): BMC Anesthesiol
                Title: BMC Anesthesiology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2253
                Publication date (Electronic): 6 July 2024
                Publication date PMC-release: 6 July 2024
                Publication date Collection: 2024
                Volume: 24
                Electronic Location Identifier: 226
                Affiliations
                GRID grid.417409.f, ISNI 0000 0001 0240 6969, The Third Affiliated Hospital of Zunyi Medical University, (The First People’s Hospital of Zunyi), ; Guizhou, China
                Author information
                https://orcid.org/0000-0001-7872-1818
                Article
                Publisher ID: 2614
                DOI: 10.1186/s12871-024-02614-6
                PMC ID: 11227182
                PubMed ID: 38971731
                SO-VID: eaa2c0ee-a51b-4ca1-bcf0-b0a89655144d
                Copyright © © The Author(s) 2024
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 16 February 2024
                Date accepted : 1 July 2024
                Funding
                Funded by: the Science and Technology Bureau of Zunyi City
                Award ID: Zunyi City KEHE HZ(2020)288
                Award ID: Zunyi City KEHE HZ(2020)288
                Award ID: Zunyi City KEHE HZ(2020)288
                Award ID: Zunyi City KEHE HZ(2020)288
                Award ID: Zunyi City KEHE HZ(2020)288
                Award ID: Zunyi City KEHE HZ(2020)288
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © BioMed Central Ltd., part of Springer Nature 2024

                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: remimazolam tosilate,propofol,total intravenous anesthesia
                Data availability:
                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: remimazolam tosilate, propofol, total intravenous anesthesia

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