Efficacy and safety of remimazolam for non-obese patients during anesthetic induction in cardiac surgery: study protocol for a multicenter randomized trial

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Abstract

Background

Valvular heart disease remains common in both developed and developing countries, and it requires timely surgical treatment when necessary. However, the stability of hemodynamics during anesthesia induction in patients undergoing valve replacement surgery is difficult to maintain due to their impaired cardiac function. Remimazolam, a novel and ultrashort-acting intravenous sedative-hypnotic, may be beneficial to stable hemodynamics, but the evidence is limited. Therefore, this study aims to evaluate the effect of remimazolam induction on hemodynamics compared with midazolam and etomidate in patients undergoing valve replacement surgery.

Methods

This is a prospective, multicenter randomized controlled trial (RCT). Three hundred and sixty-three non-obese adult patients aged 45 to 80 years old undergoing valve surgery with cardiopulmonary bypass will be randomly allocated to receive remimazolam tosilate, midazolam, or etomidate during anesthetic induction. The primary outcome is the incidence of hypotension within 20 min after the administration of investigated drugs. The hypotension is defined as systolic blood pressure (SBP) < 90 mmHg or a 30% reduction in SBP from baseline or the application of vasoactive drugs. Secondary outcomes include incidence of successful sedation, time to successful sedation, incidence of delirium and postoperative low cardiac output syndrome within 7 days after surgery, hospital mortality, mechanical ventilation time, ICU length of stay, and hospital length of stay.

Discussion

To our knowledge, this is the first prospective RCT to investigate the efficacy and safety of remimazolam induction in adult cardiac surgery compared with midazolam and etomidate. This study will provide important information on the application of remimazolam in cardiac surgery in the future.

Trial registration

Chinese Clinical Trial Registry chictr.org.cn ChiCTR2100050122. Registered on August 16, 2021.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-022-06965-8.

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Most cited references 29

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Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU).

R Dittus, S Gautam, E Ely … (2001)

Delirium is a common problem in the intensive care unit (ICU). Accurate diagnosis is limited by the difficulty of communicating with mechanically ventilated patients and by lack of a validated delirium instrument for use in the ICU. To validate a delirium assessment instrument that uses standardized nonverbal assessments for mechanically ventilated patients and to determine the occurrence rate of delirium in such patients. Prospective cohort study testing the Confusion Assessment Method for ICU Patients (CAM-ICU) in the adult medical and coronary ICUs of a US university-based medical center. A total of 111 consecutive patients who were mechanically ventilated were enrolled from February 1, 2000, to July 15, 2000, of whom 96 (86.5%) were evaluable for the development of delirium and 15 (13.5%) were excluded because they remained comatose throughout the investigation. Occurrence rate of delirium and sensitivity, specificity, and interrater reliability of delirium assessments using the CAM-ICU, made daily by 2 critical care study nurses, compared with assessments by delirium experts using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria. A total of 471 daily paired evaluations were completed. Compared with the reference standard for diagnosing delirium, 2 study nurses using the CAM-ICU had sensitivities of 100% and 93%, specificities of 98% and 100%, and high interrater reliability (kappa = 0.96; 95% confidence interval, 0.92-0.99). Interrater reliability measures across subgroup comparisons showed kappa values of 0.92 for those aged 65 years or older, 0.99 for those with suspected dementia, or 0.94 for those with Acute Physiology and Chronic Health Evaluation II scores at or above the median value of 23 (all P<.001). Comparing sensitivity and specificity between patient subgroups according to age, suspected dementia, or severity of illness showed no significant differences. The mean (SD) CAM-ICU administration time was 2 (1) minutes. Reference standard diagnoses of delirium, stupor, and coma occurred in 25.2%, 21.3%, and 28.5% of all observations, respectively. Delirium occurred in 80 (83.3%) patients during their ICU stay for a mean (SD) of 2.4 (1.6) days. Delirium was even present in 39.5% of alert or easily aroused patient observations by the reference standard and persisted in 10.4% of patients at hospital discharge. Delirium, a complication not currently monitored in the ICU setting, is extremely common in mechanically ventilated patients. The CAM-ICU appears to be rapid, valid, and reliable for diagnosing delirium in the ICU setting and may be a useful instrument for both clinical and research purposes.

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Epidemiology of valvular heart disease in the adult.

Alec Vahanian, Bernard Iung (2011)

Valvular heart disease remains common in industrialized countries, because the decrease in prevalence of rheumatic heart diseases has been accompanied by an increase in that of degenerative valve diseases. Aortic stenosis and mitral regurgitation are the two most common types of valvular disease in Europe. The prevalence of valvular disease increases sharply with age, owing to the predominance of degenerative etiologies. The burden of heart valve disease in the elderly has an important impact on patient management, given the high frequency of comorbidity and the increased risk associated with intervention in this age group. Endocarditis is an important etiology of valvular disease and is most commonly caused by Staphylococci. Rheumatic heart disease remains prevalent in developing countries.

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Global epidemiology of valvular heart disease

Sean Coffey, Ross L. Roberts-Thomson, Alex Brown … (2021)

Valvular heart disease (VHD) is a major contributor to loss of physical function, quality of life and longevity. The epidemiology of VHD varies substantially around the world, with a predominance of functional and degenerative disease in high-income countries, and a predominance of rheumatic heart disease in low-income and middle-income countries. Reflecting this distribution, rheumatic heart disease remains by far the most common manifestation of VHD worldwide and affects approximately 41 million people. By contrast, the prevalence of calcific aortic stenosis and degenerative mitral valve disease is 9 and 24 million people, respectively. Despite a reduction in global mortality related to rheumatic heart disease since 1900, the death rate has remained fairly static since 2000. Meanwhile, deaths from calcific aortic stenosis have continued to rise in the past 20 years. Epidemiological data on other important acquired and congenital forms of VHD are limited. An ageing population and advances in therapies make an examination of the changing global epidemiology of VHD crucial for advances in clinical practice and formulation of health policy. In this Review, we discuss the global burden of VHD, geographical variation in the presentation and clinical management, and temporal trends in disease burden.

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Author and article information

Contributors

Hong Yu: happyjia1990@foxmail.com

Hong-Mei Liu: 18102429203@163.com

Ping Li: 595950583@qq.com

Hai Yu: yuhai@scu.edu.cn

Bin Liu: liubinhxyy@163.com

Peng Liang:

ORCID: http://orcid.org/0000-0001-8485-1694

liangpeng_world@foxmail.com

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 7 December 2022

Publication date PMC-release: 7 December 2022

Publication date Collection: 2022

Volume: 23

Electronic Location Identifier: 984

Affiliations

[1 ]GRID grid.13291.38, ISNI 0000 0001 0807 1581, Department of Anesthesiology, West China Hospital, , Sichuan University, ; No.37 Guoxue Alley, Chengdu, 610041 Sichuan China

[2 ]Department of Anesthesiology, Wu’an First People’s Hospital, Wu’an, 056300 China

[3 ]GRID grid.13291.38, ISNI 0000 0001 0807 1581, Day Surgery Center, West China Hospital, , Sichuan University, ; No.37 Guoxue Alley, Chengdu, 610041 Sichuan China

Author information

Peng Liang http://orcid.org/0000-0001-8485-1694

Article

Publisher ID: 6965

DOI: 10.1186/s13063-022-06965-8

PMC ID: 9727858

SO-VID: 4507461f-725b-445d-ac77-73fcd1d98f83

License:

Open AccessThis 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 : 28 September 2022

Date accepted : 28 November 2022

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: randomized controlled trial,remimazolam tosilate,midazolam,etomidate,cardiac surgery,anesthetic induction

Data availability:

ScienceOpen disciplines: Medicine

Keywords: randomized controlled trial, remimazolam tosilate, midazolam, etomidate, cardiac surgery, anesthetic induction

Efficacy and safety of remimazolam for non-obese patients during anesthetic induction in cardiac surgery: study protocol for a multicenter randomized trial

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Abstract

Background

Methods

Discussion

Trial registration

Supplementary Information

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SICOT-J (Orthopedic surgery and traumatology)

Most cited references 29

Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU).

Epidemiology of valvular heart disease in the adult.

Global epidemiology of valvular heart disease

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Affiliations

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