The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

Bronchoscopy Clinical Trial

Official title:

The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116955
• Other study ID #: QYFYEC2023-111
• Status: Completed
• Start date: September 21, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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".

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Drug:
• Midazolam and sufentanil
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.
• Midazolam, sufentanil and propofol
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.
• Remazolam and sufentanil.
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.
• Remazolam, sufentanil and propofol
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.

Locations

Country	Name	City	State
China	Affiliated Hospital of Qingdao University	Shandong	Qingdao

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	The investigator needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted bronchoscopy. The score from 0 (extremely dissatisfied) to 10 (extremely satisfied).	During bronchoscopy.
Primary	Clinical satisfaction	The investigator needs to use VAS scores to evaluate satisfaction about doctors and nurses when they carry out the operation. The score from 0 (extremely dissatisfied) to 10 (extremely satisfied).	During bronchoscopy.
Primary	Patient's recovery time	The investigator needs to record the wake-up time of patients after the end of bronchoscopy.	The end of bronchoscopy (up to 2 hours).
Primary	Patient's departure time	The investigator needs to record the patient's departure time after the end of bronchoscopy.	The end of bronchoscopy (up to 2 hours).
Secondary	Induction time	Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.	Before bronchoscopy.
Secondary	Drug dosage	Induced, maintenance and total dose of midazolam, propofol.	Before bronchoscopy and during bronchoscopy.
Secondary	Additional frequency of propofol during bronchoscopy	Additional frequency of propofol during bronchoscopy.	During bronchoscopy.
Secondary	Additional frequency of 2% lidocaine during bronchoscopy	Additional frequency of 2% lidocaine during bronchoscopy.	During bronchoscopy.
Secondary	Additional dosage of 2% lidocaine during bronchoscopy	Additional dosage of 2% lidocaine during bronchoscopy.	During bronchoscopy.
Secondary	Additional dosage of propofol during bronchoscopy	Additional dosage of propofol during bronchoscopy.	During bronchoscopy.
Secondary	Patient response score during bronchoscopy	Researcher used the Behavioral Pain Scale for non intubated patients (BPS-NI) to assess their response scores. The tool consists of 3 behavioral domains: facial expressions, movements, and vocalization. The total BPS-IN value can range from 3 (no pain) to 12 (most pain).	During bronchoscopy.
Secondary	Adverse reactions during bronchoscopy	Record the number of occurrences of hypotension, hypertension, tachycardia, bradycardia, arrhythmias, hypoxemia, apnea, coughing (no wheezing during continuous coughing, considered as one coughing), and physical activity (non directive limb activity) during bronchoscopy.; After fully awake, researcher 2 used the VAS score for adverse reactions during the resuscitation process, such as dizziness, pain, nausea, breathing difficulties, etc.	During bronchoscopy
Secondary	Adverse reactions after fully awake	After fully awake, researcher used the VAS score for adverse reactions during the resuscitation process, such as dizziness, pain, nausea, breathing difficulties, etc. The score from 0 (no uncomfortable) to 10 (extremely uncomfortable).	The end of bronchoscopy (up to 2 hours).
Secondary	Patient's anxiety/depression state	Researcher used the Patient Health Questionnaire-8 (PHQ-8) to assess Patient's anxiety/depression state. The total score range of PHQ-8 is 0-24. No depressive symptoms on a score of 0-4, mild on a score of 5-9, moderate on a score of 10-14, and severe on a score of 15 or above.	Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.