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Prospective analysis of efficacy and safety of individualized administration of midazolam for sedation during bronchoscopy

Prospective analysis of efficacy and safety of individualized administration of midazolam for sedation during bronchoscopy - Prospective analysis of midazolam administration for sedation during bronchoscopy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003971
Enrollment
200
Registered
2010-07-31
Start date
2010-06-01
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

Patients undergoing diagnostic bronchoscopy

Interventions

At the start Male&lt
=65y.o. female&lt
=70 y.o. midazolam 0.075mg/kg Male&gt
65y.o. female&gt
70 y.o. midazolam 0.05mg/kg subsequent dose: half of the first dose q20min.

Sponsors

Nagoya University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are going to undergo diagnostic bronchoscopy at the Nagoya University Hospital. 2) Patients aged 20 years or older 3) Patients able to fill out a questionnaire 4) Written informed consent from the patients 5) Adequate organ function, as follows: AST/ALT <= 100 IU/L T. Bil <= 1.5 mg/dL Scr <= 1.5 mg/dL SpO2 >= 90% or PaO2 >= 60 torr (room air )

Exclusion criteria

Exclusion criteria: Patients with at least one of the following conditions are ineligible. 1) Patients with type II respiratory failure who take or need home oxygen therapy 2) Patients with obstructive sleep apnea syndrome who need positive airway pressure ventilation 3) History of myocardial infarction within 6 weeks 4) Having mental disorders unable to mutual understanding 5) History of grave drug allergic reaction or allergic reaction to midazolam 6) Acute angle-closure glaucoma 7) Neuromuscular disease (such as myasthenia gravis) 8) Patients who are taking 9) Pregnancy, breast feeding and suspected pregnancy 10) Inadequate for bronchoscopy 11) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Design outcomes

Primary

MeasureTime frame
Patient's discomfort during bronchoscopy

Secondary

MeasureTime frame
Anxiety and memory during bronchoscopy, willingness to accept a repeat bronchoscopy, complications of the procedure, vital sign during bronchoscopy, time of bronchoscopy, dose of lidocaine, diagnostic rate

Countries

Japan

Contacts

Public ContactKazuyoshi Imaizumi

Nagoya University Graduate School of Medicine Department of Respiratory Medicine

jeanluc@med.nagoya-u.ac.jp052-744-2167

Outcome results

None listed

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