Clinical trial NCT06116955: The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
Official title: The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchoscopy
Keywords: Propofol
Balanced propofol sedation
Remazolam
Bronchoscopy
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population undergoing bronchoscopy examination at Qingdao University Affiliated Hospital from December 2023 to January 2014.

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.

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".

Primary outcomes:
measure: Patient satisfaction
timeFrame: During bronchoscopy.
measure: Clinical satisfaction
timeFrame: During bronchoscopy.
measure: Patient's recovery time
timeFrame: The end of bronchoscopy (up to 2 hours).
measure: Patient's departure time
timeFrame: The end of bronchoscopy (up to 2 hours).
Secondary outcomes:
measure: Induction time
timeFrame: Before bronchoscopy.
measure: Drug dosage
timeFrame: Before bronchoscopy and during bronchoscopy.
measure: Additional frequency of propofol during bronchoscopy
timeFrame: During bronchoscopy.
measure: Additional frequency of 2% lidocaine during bronchoscopy
timeFrame: During bronchoscopy.
measure: Additional dosage of 2% lidocaine during bronchoscopy
timeFrame: During bronchoscopy.
measure: Additional dosage of propofol during bronchoscopy
timeFrame: During bronchoscopy.
measure: Patient response score during bronchoscopy
timeFrame: During bronchoscopy.
measure: Adverse reactions during bronchoscopy
timeFrame: During bronchoscopy
measure: Adverse reactions after fully awake
timeFrame: The end of bronchoscopy (up to 2 hours).
measure: Patient's anxiety/depression state
timeFrame: Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.
Other outcomes:
Locations:
city: Shandong
country: China
facility: Affiliated Hospital of Qingdao University
state: Qingdao
Study officials:
References: