NCT06116955

The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 424 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Balanced propofol sedation (BPS) is a technique proposed and developed by gastroenterologists. In recent years, multiple studies have confirmed that the use of BPS in gastrointestinal endoscopy can not only ensure patient comfort, but also reduce the incidence of respiratory and circulatory suppression. Moreover, the postoperative recovery time is short. Even for non-anesthesiologists applying BPS in gastrointestinal endoscopy , it has high safety. Compared with gastrointestinal endoscopy, bronchoscopy occupies the respiratory tract and most patients have respiratory system diseases. Therefore, it is more necessary for strict respiratory management and control of patient sedation depth. Traditional midazolam combined with opioid drugs or propofol monosedation cannot effectively meet clinical needs. The excellent sedative and analgesic effects of BPS, as well as its maintenance of respiratory and circulatory functions, make it theoretically very suitable for application in bronchoscopy. However, there is currently a lack of evidence to support the application of BPS in bronchoscopy.

Conditions

• Bronchoscopy

Interventions

Type	Name	Description
DRUG	Midazolam and sufentanil	Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.
DRUG	Midazolam, sufentanil and propofol	Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.
DRUG	Remazolam and sufentanil.	Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.
DRUG	Remazolam, sufentanil and propofol	Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.

Timeline

• Start date: 2023-09-21
• Primary completion: 2023-12-31
• Completion: 2024-01-01
• First posted: 2023-11-03
• Last updated: 2024-01-31

Locations

1 site across 1 country: China