Status:
UNKNOWN
A Randomized Single-blind Clinical Trial of the Efficacy and Safety of Remimazolam in Painless Bronchoscopy
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Bronchoscopy
Sedation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Over the past decade, bronchoscopy technology has developed rapidly and has become an important part of the diagnosis and treatment of respiratory diseases. Bronchoscopy are usually carried out under ...
Detailed Description
All patients undergoing bronchoscopy under general anesthesia will be recruited and should complete relevant preoperative examinations. The patient fasted for 6-8 hours before the operation, and an in...
Eligibility Criteria
Inclusion
- 18 to 70 years old.
- Need for bronchoscopy (for example, unexplained cough, hemoptysis, localized wheezing and hoarseness, chest X-ray and/or CT scans suggest abnormalities, examination and evaluation of lungs before surgery, chest trauma, lungs Or bronchial infectious disease).
- ASA classification I-III level.
- BMI≤30kg/m2.
- Women of childbearing age have a negative pregnancy test.
- Before the study, the patients voluntarily signed and dated the informed consent form approved by the institutional review board.
Exclusion
- Patients with known allergies to benzodiazepines, flumazenil, opioids, naloxone or certain drugs.
- Patients with long-term use of benzodiazepines or opioids.
- Patients with a history of drug abuse or alcohol abuse in the past two years.
- Bradycardia (baseline HR \<60bpm) or hypotension (baseline SAP\<100mmHg).
- Asthma or chronic obstructive pulmonary disease(COPD) or FEV1\<1.0L.
- SpO2 \<90% before bronchoscopy.
- Patients who received any study drug within 30 days before screening or less than 7 half-lives of the drug.
- Any patient with cognitive impairment or inability to provide informed consent.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT04919174
Start Date
April 23 2021
End Date
October 1 2022
Last Update
June 9 2021
Active Locations (1)
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1
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China, 310000