Randomized single-blind comparative study of midazolam alone administration and midazolam/pethidine combination administration against pain level during respiratory endoscopy (KURM005study)

Randomized single-blind comparative study of midazolam alone administration and midazolam/pethidine combination administration against pain level during respiratory endoscopy (KURM005study) - Comparative study of analgesic/sedating midazolam alone and midazolam/pethidine combination at the time of respiratory endoscopy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032230

Enrollment

100

Registered

2018-08-15

Start date

2018-08-15

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

Lung tumor and mediastinal tumor

Interventions

At the start of respiratory endoscopy, administration of 5 mL of physiological saline (placebo) and 2 mL of midazolam (1mg/mL). Midazolam (1 mg / mL) is additionally administered 1 mL at a time depen

s pain under examination. At the start of bronchoscopy, 5 mL of pethidine hydrochloride (3.5 mg/mL) and 2 mL of midazolam (1 mg/mL). Midazolam (1mg/mL) is additionally administered 1 mL at a time dep

s pain under examination

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients whose age is between 20 and 80 years old when obtaining consent. (2) Patients scheduled to undergo respiratory endoscopy for biopsy of lung tumor or mediastinal tumor. (3) Patietns who obtained document consent by their own voluntary intention concerning participation in this exam.

Exclusion criteria

Exclusion criteria: (1) Patients who are allergic to the drugs used in this study and have drug hypersensitivity (2) Patients with acute narrow angle glaucoma (3) Patients with myasthenia gravis (4) Uncontrollable bronchial asthma patients (5) Patients whose severe respiratory depression is confirmed before the examination (6) Patients having heart failure secondary to chronic lung disease (7) Patients in convulsive state (8) Patients whose severe liver failure has been confirmed (9) Pregnant women and patients who may be pregnant or breast-feeding patients (10) Patients taking HIV protease inhibitors or monoamine inhibitors (11) Patients taking orally administered opioids (12) Other patients judged inappropriate by the person in charge of this examination

Design outcomes

Primary

Measure	Time frame
The visual analogue scale (VAS) of the questionnaire "You may reexecute respiratory endoscopy".	—

Secondary

Measure	Time frame
Percentage of patients who responded that they may reexecute respiratory endoscopy of subjects VAS value of degree of suffering and cough during examination by the subject. Dosage of xylocaine and midazolam (mg). The VAS of the cough degree of the examinee. Effectiveness and safety. (modified observer's assessment of alertness/sedation scale (moaa/s)under examination, tissue collection rate, diagnostic rate, examination time, SpO2, blood pressure, history of use of Flumazenil, adverse events, VAS in a questionnaire.)	—

Measure

Time frame

Percentage of patients who responded that they may reexecute respiratory endoscopy of subjects VAS value of degree of suffering and cough during examination by the subject. Dosage of xylocaine and midazolam (mg). The VAS of the cough degree of the examinee. Effectiveness and safety. (modified observer's assessment of alertness/sedation scale (moaa/s)under examination, tissue collection rate, diagnostic rate, examination time, SpO2, blood pressure, history of use of Flumazenil, adverse events, VAS in a questionnaire.)

—

Countries

Japan

Contacts

Public ContactMOTOKO TACHIHARA

Kobe University Graduate School of Medicine Division of Respiratory Medicine, Department of Internal Medicine

mt0318@med.kobe-u.ac.jp078-382-5660

Outcome results

None listed

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