Intravenous conscious sedation by use of midazolam during the examination of bronchoscopy

Not Applicable

• Conditions: Patients for indication of bronchoscopic observation or procedure on central bronchial lesion.

• Registration Number: JPRN-UMIN000005547
• Lead Sponsor: Department of Respiratory Medicine National Center for Global health and Medicine

Brief Summary

Online publication in May 06 2018

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-06
• Study Completion: 2013-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
a)Relationship between pharmacokinetics and genetic polymorphism b) Relationship between pharmacokinetics and tolerance during bronchoscopy