Evidence map›Paper›PMID 38760702›Full record

ArticleBMC pulmonary medicine2024

A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design.

Hee Yun Seol, Kyung Soo Hong, Jong Geol Jang, Seong Mi Moon, Sun-Hyung Kim, Jun Yeun Cho, Bumhee Yang, Seonok Kim, Chang-Min Choi, Wonjun Ji and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pulmonary medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06275594 (A Prospective, Open-label, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam in patienTs Undergoing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

NCT06275594 phase2unknown statusnot on this map

A Prospective, Open-label, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam in patienTs Undergoing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration: REST Trial

TypeinterventionalSponsorYeungnam University HospitalRan2024 to 2025Enrolled330ConditionsMidazolam, RemimazolamArmsByfavo, Midazolam
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

11 authors.

Hee Yun Seol *Department of Internal Medicine, Pusan National University School of Medicine, Busan, Republic of Korea.
Kyung Soo Hong *Division of Pulmonology and Allergy, Department of Internal Medicine, College of Medicine, Yeungnam University and Respiratory Center, Yeungnam University Medical Center, 170 Hyeonchung-Ro, Namgu, Daegu, 42415, Republic of Korea.
Jong Geol JangDivision of Pulmonology and Allergy, Department of Internal Medicine, College of Medicine, Yeungnam University and Respiratory Center, Yeungnam University Medical Center, 170 Hyeonchung-Ro, Namgu, Daegu, 42415, Republic of Korea.
Seong Mi MoonDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
Sun-Hyung KimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
Jun Yeun ChoDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
Bumhee YangDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
Seonok KimDepartment of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Chang-Min ChoiDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
Wonjun Ji *Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea. wonjunji@amc.seoul.kr.
June Hong Ahn *Division of Pulmonology and Allergy, Department of Internal Medicine, College of Medicine, Yeungnam University and Respiratory Center, Yeungnam University Medical Center, 170 Hyeonchung-Ro, Namgu, Daegu, 42415, Republic of Korea. fireajh@gmail.com.

Funding

Korean Association for the Study of Targeted Therapy (KASTT) affiliated with Korean Association for Lung Cancer KASTT-20230211
6 · The paper itself

Abstract

backgroundRemimazolam is safe and effective for moderate sedation during flexible bronchoscopy, but its safety and efficacy during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) remains undetermined. The REST trial (NCT06275594) will be a prospective randomized study of remimazolam in patients undergoing EBUS-TBNA with conscious sedation. The primary aim is to evaluate whether remimazolam is safe and effective for moderate sedation during EBUS-TBNA compared to real-world midazolam and on-label midazolam.

methodsThe REST trial will recruit 330 patients from four university hospitals with mediastinal lesions suspected of being lung cancer who are eligible for EBUS-TBNA under moderate sedation. The participants will be randomized into groups using remimazolam, real-world midazolam, and on-label midazolam (US prescribing information dosage) to perform EBUS-TBNA for procedural sedation. The primary endpoint will be procedural success using composite measures. DISCUSSION: The REST trial will prospectively evaluate the efficacy and safety of remimazolam during EBUS-TBNA under moderate sedation. It will provide information for optimizing sedation modalities and contribute to practical benefits in patients undergoing EBUS-TBNA.

trial registrationClinicalTrials.gov (NCT06275594). Prospectively registered on 15 February 2024.

Indexed as

Endoscopic Ultrasound-Guided Fine Needle AspirationHypnotics and SedativesLung NeoplasmsMidazolamProcedural SedationAdultBenzodiazepinesBronchoscopyFemaleHumansMaleMiddle AgedProspective StudiesRandomized Controlled Trials as TopicBenzodiazepinesHypnotics and SedativesMidazolamremimazolamEndobronchial ultrasonographyProtocolPulmonary medicineRemimazolamSedation

Identifiers

PMID38760702
PMCPMC11100028

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Registered trials

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.