BronchoscopyNCT03890094
Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study
An observational study of Bronchoscopy and Sedation, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The aim of this study was to determine the safety and efficacy of sufentanil combined with midazolam in bronchoscopy under conscious sedation. A retrospective analysis was conducted on all patients undergoing bronchoscopy applying sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy, Sedation
- What is being tested?
- Sufentanil
- Type of treatment
- Injection or infusion
- How many people
- 11,158 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 May 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: According to guidelines of bronchoscopy, patients had no food by mouth for 4h and to allow clear fluids by mouth up to 2 h before bronchoscopy. Oxygen supplementation was given to the patients through the nasal cannula (2-5L/min, adjusted as needed). 2% lidocaine was applied for topical anesthesia. Sufentanil and midazolam were applied intravenously.
Who may be able to join
- Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017
Who cannot join
- Patients who had undergone bronchoscopy not applying topical lidocaine, sufentanil and midazolam under conscious sedation
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
The aim of this study was to determine the safety and efficacy of sufentanil combined with midazolam in bronchoscopy under conscious sedation. A retrospective analysis was conducted on all patients undergoing bronchoscopy applying sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017.
- Conditions
- Bronchoscopy, Sedation
- Being tested
- Sufentanil
- Keywords
- Sufentanil, Bronchoscopy, Conscious sedation, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Patients were applied sufentanil and midazolam intravenously and topical anesthetized.
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil and Midazolam | Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017 were included in this study. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation
Percentage of patients whose oxygen saturation decreased to lower than 80% during procedure
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 May 2018
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, Professor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890094
- Sponsor's protocol ID
- Suretro2013
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study
- ClinicalTrials.gov ID
- NCT03890094
- Acronym / sponsor ID
- Suretro2013
- Conditions
- Bronchoscopy, Sedation
- Keywords
- Sufentanil, Bronchoscopy, Conscious sedation, midazolam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,158 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 26 Mar 2019 (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 aim of this study was to determine the safety and efficacy of sufentanil combined with midazolam in bronchoscopy under conscious sedation. A retrospective analysis was conducted on all patients undergoing bronchoscopy applying sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sufentanil and Midazolam | – | Drug: SufentanilPatients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017 were included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- According to guidelines of bronchoscopy, patients had no food by mouth for 4h and to allow clear fluids by mouth up to 2 h before bronchoscopy. Oxygen supplementation was given to the patients through the nasal cannula (2-5L/min, adjusted as needed). 2% lidocaine was applied for topical anesthesia. Sufentanil and midazolam were applied intravenously.
Key inclusion criteria (1 listed)
- Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017
Key exclusion criteria (1 listed)
- Patients who had undergone bronchoscopy not applying topical lidocaine, sufentanil and midazolam under conscious sedation
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 |
|---|---|---|
| SufentanilPatients were applied sufentanil and midazolam intravenously and topical anesthetized. | Drug | Sufentanil and Midazolam |
Primary outcome
Oxygen desaturation
Time frame: during the procedure
Percentage of patients whose oxygen saturation decreased to lower than 80% during procedure
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 2 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Bronchoscopy
Not yet recruiting
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
Lung Cancer
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
Enrolling by invitationPhase 2
Effects of Bronchial Segmental Endotoxin Instillation in Humans
Acute Lung Inflammation
Active, not recruitingObservational study
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Lung Biopsy, Lung Cancer
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
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.
Shiyue Li, Professor principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 and Sedation, run by Guangzhou Institute of Respiratory Disease 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 1 inclusion and 1 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 2 Apr 2019. 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?
Oxygen desaturation (time frame: during the procedure). 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 2 Apr 2019.