An observational study in Bronchoscopy, sponsored by The Affiliated Hospital of Qingdao University. Completed at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by The Affiliated Hospital of Qingdao University · Observational
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.
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.
The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Population undergoing bronchoscopy examination at Qingdao University Affiliated Hospital from December 2023 to January 2014.
Exclusion Criteria:
Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.
Drug: Midazolam and sufentanil
Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.
Drug: Midazolam, sufentanil and propofol
Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.
Drug: Remazolam and sufentanil.
Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.
Drug: Remazolam, sufentanil and propofol
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.
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).
Time frame: During bronchoscopy.
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).
Time frame: During bronchoscopy.
Patient's recovery time
The investigator needs to record the wake-up time of patients after the end of bronchoscopy.
Time frame: The end of bronchoscopy (up to 2 hours).
Patient's departure time
The investigator needs to record the patient's departure time after the end of bronchoscopy.
Time frame: The end of bronchoscopy (up to 2 hours).
Induction time
Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.
Time frame: Before bronchoscopy.
Drug dosage
Induced, maintenance and total dose of midazolam, propofol.
Time frame: Before bronchoscopy and during bronchoscopy.
Additional frequency of propofol during bronchoscopy
Additional frequency of propofol during bronchoscopy.
Time frame: During bronchoscopy.
Additional frequency of 2% lidocaine during bronchoscopy
Additional frequency of 2% lidocaine during bronchoscopy.
Time frame: During bronchoscopy.
Additional dosage of 2% lidocaine during bronchoscopy
Additional dosage of 2% lidocaine during bronchoscopy.
Time frame: During bronchoscopy.
Additional dosage of propofol during bronchoscopy
Additional dosage of propofol during bronchoscopy.
Time frame: During bronchoscopy.
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).
Time frame: During bronchoscopy.
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.
Time frame: During bronchoscopy
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).
Time frame: The end of bronchoscopy (up to 2 hours).
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.
Time frame: Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University