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A Randomized Single-blind Clinical Trial of the Efficacy and Safety of Remimazolam in Painless Bronchoscopy

NCT04919174 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2021-06-09

No results posted yet for this study

Summary

Over the past decade, bronchoscopy technology has developed rapidly and has become an important part of the diagnosis and treatment of respiratory diseases. Bronchoscopy are usually carried out under monitored anesthesia care (MAC), which can relieve the anxiety of the patient, make the operation easier, and improve the completion rate of bronchoscopy. At present, bronchoscopy has widely used midazolam, propofol, short-acting opioids, and newer sedatives such as dexmedetomidine, but each drug has its limitations. Dexmedetomidine is widely used in non-intubation general anesthesia and sedation during short outpatient surgery. However, rapid and high-dose infusion of dexmedetomidine leads to dose-dependent hypotension, temporary hypertension, bradycardia, and excessive sedation, causing hemodynamic fluctuations. At the same time, it has slow onset and metabolism. This may be a potential risk for some elderly patients with many underlying diseases and unstable hemodynamics. Remimazolam is an ultra-short-acting benzodiazepine. It has the advantages of short action time, low accumulation, low risk of respiratory depression, and reversibility. We believe that remimazolam can improve the onset time and resuscitation time, to achieve sufficient sedation, improve the success rate of bronchoscopy, while reducing the patient's oxygen saturation drop during the operation, postoperative opioid-related nausea and vomiting, postoperative delirium and other related adverse events. This study is a randomized controlled trial to confirm the above hypothesis.

Conditions

  • Bronchoscopy
  • Sedation

Interventions

DRUG

Remimazolam

Sedation with remimazolam

DRUG

Dexmedetomidine

Sedation with dexmedetomidine

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Min Yan, MD · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2022-04-30
Completion
2022-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919174 on ClinicalTrials.gov