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Safety and efficacy of sedation with midazolam during bronchoscopy

Safety and efficacy of sedation with midazolam during bronchoscopy - Sedation with midazolam during bronchoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000023619
Enrollment
100
Registered
2016-12-01
Start date
2016-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory disease, which is an indication of flexible bronchoscopy

Interventions

None listed

Sponsors

Department of Respiratory Medicine Nagoya University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing bronchoscopy in Nagoya University Hospital 2. Age is 20 years or older 3. Written consent for participation in the study from the patient himself has been obtained 4. Patient with mental state that can enforce the investigation by questionaire 5. Laboratory test values within the preceding 14 days registration meets the following criteria: a) AST / ALT < 3 times the facility references value upper limit b) 1.5 times the total bilirubin value < facility reference value upper limit c) following serum creatinine 1.5mg / dl d) SpO2 > 90% in the room air

Exclusion criteria

Exclusion criteria: 1. Patients with SpO2 <90% in the room air 2. There is a history of severe drug hypersensitivity, including hypersensitivity to midazolam 3. Patients with a neuromuscular disease 4. Patients with acute angle-closure glaucoma 5. Patients with myocardial infarction within-onset 6 weeks 6. Patients with other serious complications 7. Patients whom the attending physician has determined to be inappropriate as a subject of the present study

Design outcomes

Primary

MeasureTime frame
Occurrence rate of hypoxemia during bronchoscopy

Secondary

MeasureTime frame
1. Blood concentrations of midazolam (after the initial dose, after adding administration) 2. MOAA/S scale 3. The bispectral index (BIS) 4. Questionnaire about the sedation 5. Adverse events 6. Correlation between gene polymorphism and efficacy or safety of sedation

Countries

Japan

Contacts

Public ContactShotaro Okachi

Nagoya University Hospital Department of Respiratory Medicine

s.okachi@med.nagoya-u.ac.jp052-744-2167

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026