BronchoscopyNCT06116955
The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
An observational study of Bronchoscopy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Midazolam and sufentanil, Midazolam, sufentanil and propofol and Remazolam and sufentanil.
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population undergoing bronchoscopy examination at Qingdao University Affiliated Hospital from December 2023 to January 2014.
Who may be able to join
- American Society of Anesthesiologists classes I-IV ;
- 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;
- Normal communication skills and able to cooperate in completing this study;
- Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form".
Who cannot join
- Patients with contraindications or allergies to anesthesia;
- Individuals with a history of alcoholism or drug abuse;
- Patients with contraindications for puncture of the cricoid membrane;
- Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels;
- Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies;
- Patients who require laryngeal mask or tracheal intubation for assisted ventilation during the examination process;
- Patients undergoing rigid bronchoscopy treatment;
- Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bronchoscopy
- Being tested
- Midazolam and sufentanil, Midazolam, sufentanil and propofol, Remazolam and sufentanil., Remazolam, sufentanil and propofol
- Keywords
- Propofol, Balanced propofol sedation, Remazolam, Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam and sufentanilDrug
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.
Midazolam, sufentanil and propofolDrug
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.
Remazolam and sufentanil.Drug
Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.
Remazolam, sufentanil and propofolDrug
Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.
| Study group | Role | What they receive |
|---|---|---|
| S-M group | Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy. Receives: Drug: Midazolam and sufentanil | |
| S-M-P group | Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy. Receives: Drug: Midazolam, sufentanil and propofol | |
| S-R group | Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy. Receives: Drug: Remazolam and sufentanil. | |
| S-R-P group | Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy. Receives: Drug: Remazolam, sufentanil and propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: During bronchoscopy.
Patient's recovery time
The investigator needs to record the wake-up time of patients after the end of bronchoscopy.
Measured: 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.
Measured: The end of bronchoscopy (up to 2 hours).
Secondary outcomes (10)
Induction time
Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.
Measured: Before bronchoscopy.
Drug dosage
Induced, maintenance and total dose of midazolam, propofol.
Measured: Before bronchoscopy and during bronchoscopy.
Additional frequency of propofol during bronchoscopy
Additional frequency of propofol during bronchoscopy.
Measured: During bronchoscopy.
Additional frequency of 2% lidocaine during bronchoscopy
Additional frequency of 2% lidocaine during bronchoscopy.
Measured: During bronchoscopy.
Additional dosage of 2% lidocaine during bronchoscopy
Additional dosage of 2% lidocaine during bronchoscopy.
Measured: During bronchoscopy.
Additional dosage of propofol during bronchoscopy
Additional dosage of propofol during bronchoscopy.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start21 Sep 2023
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jixiangyu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116955
- Sponsor's protocol ID
- QYFYEC2023-111
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT06116955
- Acronym / sponsor ID
- QYFYEC2023-111
- Conditions
- Bronchoscopy
- Keywords
- Propofol, Balanced propofol sedation, Remazolam, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S-M group | – | Drug: Midazolam and sufentanilMidazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy. |
| S-M-P group | – | Drug: Midazolam, sufentanil and propofolMidazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy. |
| S-R group | – | Drug: Remazolam and sufentanil.Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy. |
| S-R-P group | – | Drug: Remazolam, sufentanil and propofolRemazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population undergoing bronchoscopy examination at Qingdao University Affiliated Hospital from December 2023 to January 2014.
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists classes I-IV ;
- 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;
- Normal communication skills and able to cooperate in completing this study;
- Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form".
Key exclusion criteria (8 listed)
- Patients with contraindications or allergies to anesthesia;
- Individuals with a history of alcoholism or drug abuse;
- Patients with contraindications for puncture of the cricoid membrane;
- Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels;
- Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam and sufentanilPatients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani. | Drug | S-M group |
| Midazolam, sufentanil and propofolPatients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol. | Drug | S-M-P group |
| Remazolam and sufentanil.Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani. | Drug | S-R group |
| Remazolam, sufentanil and propofolPatients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol. | Drug | S-R-P group |
Primary outcome
Patient satisfaction
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).
Clinical satisfaction
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).
Patient's recovery time
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.
Patient's departure time
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.
10 secondary outcomes
Induction time
Time frame: Before bronchoscopy.
Drug dosage
Time frame: Before bronchoscopy and 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.
Patient response score during bronchoscopy
Time frame: During bronchoscopy.
Adverse reactions during bronchoscopy
Time frame: During bronchoscopy
Adverse reactions after fully awake
Time frame: The end of bronchoscopy (up to 2 hours).
Patient's anxiety/depression state
Time frame: Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscopy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: During bronchoscopy.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.