Patients for indication of bronchoscopic observation or procedure on central bronchial lesion.
Conditions
Interventions
After premedication for examination of bronchoscopy(BF), 0.03 mg/kg of midazolam is administered intravenously for 2 min. Blood sample is taken at 9 time points for pharmacokinetics. Ramsay sedative
Sponsors
Department of Respiratory Medicine National Center for Global health and Medicine
Department of drug metabolism and disposition Meiji pharmaceutical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient is suitable for bronchoscopic observation and procedure on central bronchial disease. 2)Age is more than and equal to 20 years. 3)Eastern Cooperative Oncology Group performance status of 0-3 4)Adequate pulmonary and cardiac function Pulmonary function; pO2; more than and equal to 70 torr pCO2; more than and equal to 50 torr FEV1.0; more than and equal to 1.0 L BNP;more than and equal to 1.5 mg/d Ejection Fraction; more than and equal to 50% 5)Adequate renal and hepatic function Liver; Aspartate aminotransferase and alanine aminotransferase levels; below 2 times of upper limits of normal level total bilirubin level; less than and equal to 3.0 mg/dl Kidney;Creatinine; < 2.0 mg/dL Creatinine clearance; more than and equal to 50 ml/min BUN ; less than and equal to 25 mg/dl 6)Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of severe allergic reaction of midazolam 2)Contraindication of midazolam 3)Contraindication or relative contraindication of bronchoscopy Respiratory diseases Chronic respiratory failure type II Symptomatic vena cava syndrome Cardiac diseases Uncontrolled cardiac failure Myocardial ischemia or unstable angina within 8 weeks Uncontrolled arrhythmia Renal diseases Renal failure treated by hemodialysis Central Nervous system Cerebrovascular diseases within 8 weeks Hepatic diseases Liver cirrhosis with Child's C Fulminant hepatitis Hepatic failure 4)History of severe allergic reaction of local anesthesia (xylocaine) 5)Pregnant status or lactation 6)Psychic disease or status 7)Evidence of HIV infection 8)Other ineligible status judged by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Pharmacokinetics (a total of 9 points) 2)Ramsay sedative score (before and after bronchoscopy) 3)Visual analog scale(VAS)on Bronchoscopy 4)Adverse effect and safety | — |
Secondary
| Measure | Time frame |
|---|---|
| a)Relationship between pharmacokinetics and genetic polymorphism b) Relationship between pharmacokinetics and tolerance during bronchoscopy | — |
Countries
Japan
Contacts
Public ContactYuichiro Takeda
National Center for Global health and Medicine Department of Respiratory Medicine
Outcome results
None listed