Evidence map›Paper›PMID 39528975›Full record

Trial reportBMC anesthesiology2024

Efficacy and safety of remimazolam tosilate in anesthesia for short otolaryngology surgery.

Wen Cheng, Yi Cheng, Hongying He, Dandan Zhou, Jing Wang, Yi Zhang, Zhao Wang

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC anesthesiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Wen ChengDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
Yi ChengDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
Hongying HeDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
Dandan ZhouDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
Jing WangDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
Yi ZhangDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China. zyzy@zmu.edu.cn.
Zhao WangDepartment of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China. zy2ane@126.com.

Funding

Beijing Hongyi Medical Development Foundation HY20210037-A-09Science and Technology Fund project of Guizhou Provincial Health Commission gzwkj2022-386
6 · The paper itself

Abstract

backgroundRemimazolam tosilate represents the novel ultrashort-acting benzodiazepine drug. This work focused on exploring whether remimazolam tosilate was effective and safe in anesthesia for short otolaryngology surgery in adults, and optimize its medication regimen, thus providing a theoretical basis for its widespread clinical application.

methodsThe present unicentric, double-blind, randomized controlled study enrolled altogether 85 otolaryngology surgery patients aged 18-60 years, and they were divided as remimazolam (RM, 42 cases) or midazolam (MD, 43 cases) group. Efficacy outcomes included successful sedation time, sedation effect (Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score), bispectral index values (BIS), and postoperative recovery. The safety outcomes were patient vital signs at each time point (before induction (T0), 2 min and 5 min after trial drug treatment (T1 and T2 separately), during successful intubation (T3), at the end of surgery (T4), during extubation (T5), and at the time of exiting the room (T6)), any adverse reactions (AEs) during perioperative period, and patient satisfaction with anesthesia experience.

resultsDemographics were not significantly different in both groups (P > 0.05). RM group had significantly decreased successful sedation time relative to MD group (P < 0.05), while increased successful sedation rate (100%) relative to MD group (90.70%, P = 0.116). RM group showed decreased MOAA/S score and BIS value compared with MD group at T1 and T2 (P < 0.05). The spontaneous respiration recovery time and extubation time were not significantly different in both groups (P > 0.05), but RM group exhibited decreased discharge time compared with MD group (P < 0.05). Compared with MD group, the RM group had lower blood pressure (BP) at T3 (P < 0.05); whereas higher heart rate (HR) and respiration rate (RR) at T1 and T2 (P < 0.05). Difference in AEs was not of statistical significance. Finally, RM group exhibited the increased satisfaction of anesthesia experience compared with MD group (P < 0.05).

conclusionRemimazolam tosilate is effective on anesthesia for short otolaryngology surgery. Remimazolam shows the rapid onset, stable circulation, fast postoperative recovery, no increase in perioperative AEs, and high satisfaction with anesthesia experience compared with midazolam.

trial registrationhttps://www.chictr.org.cn/ (ChiCTR2200067123) on 27/12/2022. This study was consistent with CONSORT guidelines.

Indexed as

BenzodiazepinesMidazolamOtorhinolaryngologic Surgical ProceduresAdolescentAdultAnesthesia Recovery PeriodDouble-Blind MethodFemaleHumansHypnotics and SedativesMaleMiddle AgedPatient SatisfactionYoung AdultBenzodiazepinesHypnotics and SedativesMidazolamremimazolamGeneral anesthesiaOtolaryngology surgeryRemimazolam tosilate

Identifiers

PMID39528975
PMCPMC11552106

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.