Clinical trial
The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
Name
QYFYEC2023-111
Description
The purpose of this study is to investigate the feasibility of using balanced propofol sedation for bronchoscopy. And screen out the optimal balanced propofol sedation compatibility plan.
Trial arms
Trial start
2023-09-21
Estimated PCD
2023-12-31
Trial end
2024-01-01
Status
Completed
Treatment
Midazolam and sufentanil
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.
Arms:
S-M group
Midazolam, sufentanil and propofol
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.
Arms:
S-M-P group
Remazolam and sufentanil.
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.
Arms:
S-R group
Remazolam, sufentanil and propofol
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.
Arms:
S-R-P group
Size
424
Primary endpoint
Patient satisfaction
During bronchoscopy.
Clinical satisfaction
During bronchoscopy.
Patient's recovery time
The end of bronchoscopy (up to 2 hours).
Patient's departure time
The end of bronchoscopy (up to 2 hours).
Eligibility criteria
Inclusion Criteria:
1. American Society of Anesthesiologists classes I-IV ;
2. Patients undergo painless bronchoscopy, including bronchoscopic biopsy (bronchoscopic lesion biopsy, bronchial mucosal biopsy, bronchoscopic transmural lung biopsy, bronchoscopic needle aspiration biopsy) ,bronchoalveolar lavage and bronchoscopic treatment;
3. Normal communication skills and able to cooperate in completing this study;
4. Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form".
Exclusion Criteria:
1. Patients with contraindications or allergies to anesthesia;
2. Individuals with a history of alcoholism or drug abuse;
3. Patients with contraindications for puncture of the cricoid membrane;
4. Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels;
5. Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies;
6. Patients who require laryngeal mask or tracheal intubation for assisted ventilation during the examination process;
7. Patients undergoing rigid bronchoscopy treatment;
8. Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 424, 'type': 'ACTUAL'}}
Updated at
2024-01-31
1 organization
3 products
1 indication
Organization
The Affiliated Hospital of Qingdao UniversityProduct
Midazolam + SufentanilIndication
BronchoscopyProduct
Remazolam