The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

NCT ID: NCT06116955

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 424 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-01-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

S-M group

Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.

Midazolam and sufentanil

Intervention Type: DRUG

Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.

S-M-P group

Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.

Midazolam, sufentanil and propofol

Intervention Type: DRUG

Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.

S-R group

Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.

Remazolam and sufentanil.

Intervention Type: DRUG

Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.

S-R-P group

Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.

Remazolam, sufentanil and propofol

Intervention Type: DRUG

Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.

Interventions

Midazolam and sufentanil

Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.

Intervention Type: DRUG

Midazolam, sufentanil and propofol

Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.

Intervention Type: DRUG

Remazolam and sufentanil.

Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.

Intervention Type: DRUG

Remazolam, sufentanil and propofol

Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.

Intervention Type: DRUG

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".

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

jixiangyu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiliated Hospital of Qingdao University

Shandong, Qingdao, China

Countries

China

Other Identifiers

QYFYEC2023-111

Identifier Type: -

Identifier Source: org_study_id