Affiliated Hospital of Qingdao University
Shandong, Qingdao, China
NCT Number: NCT06116955
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.
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Notify Me18 year–100 year
All sexes
Observational
Shandong, Qingdao, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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).
Time frame: The end of bronchoscopy (up to 2 hours).
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).
The investigator needs to record the patient's departure time after the end of bronchoscopy.
Time frame: Before bronchoscopy.
Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.
Time frame: Before bronchoscopy and during bronchoscopy.
Induced, maintenance and total dose of midazolam, propofol.
Time frame: During bronchoscopy.
Additional frequency of propofol during bronchoscopy.
Time frame: During bronchoscopy.
Additional frequency of 2% lidocaine during bronchoscopy.
Time frame: During bronchoscopy.
Additional dosage of 2% lidocaine during bronchoscopy.
Time frame: During bronchoscopy.
Additional dosage of propofol during bronchoscopy.
Time frame: 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
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: 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).
Time frame: 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.
The Affiliated Hospital of Qingdao University
Other
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