Sedation ComplicationPhase 4NCT04211298
Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
A Phase 4 study testing Dexmedetomidine and Propofol in people with Sedation Complication, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol. The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sedation Complication
- What is being tested?
- Dexmedetomidine and Propofol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2019to 1 Aug 2020
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center
Who cannot join
- known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine > 2 mg/dL) or hepatic impairment (elevated liver enzymes > 2 times normal), haemodynamic instability (bradycardia with HR < 50 bpm or hypotension with SBP < 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Mordechai R Kramer, MD
Mordechai R Kramer, MD
About this study
The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.
The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications
- Conditions
- Sedation Complication
- Being tested
- Dexmedetomidine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine will be used for sedation during bronchoscopy
PropofolDrug
Propofol
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Dexmedetomidine will be used for sedation during bronchoscopy Receives: Drug: Dexmedetomidine |
| Propofol | Placebo comparator | Propofol will be used for sedation during bronchoscopy Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of de-saturation events
Number of events during bronchoscopy when saturation level decreased under 90%
Measured: During the procedure
Oxygen saturation time < 90%
Total time during the procedure that the oxygen saturation was under 90%
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 Dec 2019
- Study start1 Dec 2019
- Primary completion30 May 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedation ComplicationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mordechai Kremer, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211298
- Sponsor's protocol ID
- 0312-19-RMC
- Status last verified
- Dec 2019
- First submitted
- 24 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pertzov B, Krasulya B, Azem K, Shostak Y, Izhakian S, Rosengarten D, Kharchenko S, Kramer MR. Dexmedetomidine versus propofol sedation in flexible bronchoscopy: a randomized controlled trial. BMC Pulm Med. 2022 Mar 15;22(1):87. doi: 10.1186/s12890-022-01880-9.
PubMed 35291989
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04211298
- Acronym / sponsor ID
- 0312-19-RMC
- Conditions
- Sedation Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 26 Dec 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 study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.
The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine will be used for sedation during bronchoscopy |
| Propofol | Placebo comparator | Drug: PropofolPropofol will be used for sedation during bronchoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center
Key exclusion criteria (1 listed)
- known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine > 2 mg/dL) or hepatic impairment (elevated liver enzymes > 2 times normal), haemodynamic instability (bradycardia with HR < 50 bpm or hypotension with SBP < 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine will be used for sedation during bronchoscopy | Drug | Dexmedetomidine |
| PropofolPropofol | Drug | Propofol |
Primary outcome
number of de-saturation events
Time frame: During the procedure
Number of events during bronchoscopy when saturation level decreased under 90%
Oxygen saturation time < 90%
Time frame: During the procedure
Total time during the procedure that the oxygen saturation was under 90%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 35291989Pertzov B, Krasulya B, Azem K, Shostak Y, Izhakian S, Rosengarten D, Kharchenko S, Kramer MR. Dexmedetomidine versus propofol sedation in flexible bronchoscopy: a randomized controlled trial. BMC Pulm Med. 2022 Mar 15;22(1):87. doi: 10.1186/s12890-022-01880-9.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Propofol in people with Sedation Complication, run by Rabin Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 26 Dec 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barak Pertzov, MD (972548080196, pertzovb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of de-saturation events (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211298, which also lists 1 linked publication.
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 26 Dec 2019.