The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

Completed

• Conditions: Bronchoscopy
• Interventions: Drug: Midazolam and sufentanil; Drug: Midazolam, sufentanil and propofol; Drug: Remazolam and sufentanil.; Drug: Remazolam, sufentanil and propofol

• Registration Number: NCT06116955
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Study Timeline

• Study Start: 2023-09-21
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-29
• Study First Posted: 2023-11-03
• Primary Completion: 2023-12-31
• Status Verified: 2024-01
• Study Completion: 2024-01-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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".

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
S-M group	Midazolam and sufentanil	Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.
S-M-P group	Midazolam, sufentanil and propofol	Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.
S-R group	Remazolam and sufentanil.	Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.
S-R-P group	Remazolam, sufentanil and propofol	Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	During bronchoscopy.	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).
Patient's recovery time	The end of bronchoscopy (up to 2 hours).	The investigator needs to record the wake-up time of patients after the end of bronchoscopy.
Patient's departure time	The end of bronchoscopy (up to 2 hours).	The investigator needs to record the patient's departure time after the end of bronchoscopy.
Clinical satisfaction	During bronchoscopy.	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).

Secondary Outcome Measures

Name	Time	Method
Drug dosage	Before bronchoscopy and during bronchoscopy.	Induced, maintenance and total dose of midazolam, propofol.
Additional frequency of 2% lidocaine during bronchoscopy	During bronchoscopy.	Additional frequency of 2% lidocaine during bronchoscopy.
Additional dosage of 2% lidocaine during bronchoscopy	During bronchoscopy.	Additional dosage of 2% lidocaine during bronchoscopy.
Additional frequency of propofol during bronchoscopy	During bronchoscopy.	Additional frequency of propofol during bronchoscopy.
Induction time	Before bronchoscopy.	Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.
Additional dosage of propofol during bronchoscopy	During bronchoscopy.	Additional dosage of propofol during bronchoscopy.
Patient response score during bronchoscopy	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).
Adverse reactions during bronchoscopy	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.
Adverse reactions after fully awake	The end of bronchoscopy (up to 2 hours).	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).
Patient's anxiety/depression state	Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.	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.

Trial Locations

Locations (1)

Affiliated Hospital of Qingdao University; 🇨🇳 Shandong, Qingdao, China