Obstructive Sleep Apnea of AdultPhase 4NCT03091894
Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy
A Phase 4 study testing Propofol and Dexmedetomidine in people with Obstructive Sleep Apnea of Adult, run by Essam Fathi at 1 site in Egypt.
Trial summary
This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Apr 2017to 8 Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years
- patients with obstructive sleep apnea
- ASA 1and2
Who cannot join
- patient refusal
- age less than 18 years
- morbid obesity
- known or suspected allergy to the studied drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial
This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.
Read the detailed description
Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Propofol, Dexmedetomidine
- Keywords
- Dexmedetomidine, Sleep, Endoscopy, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called diprivan
propofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute
DexmedetomidineDrug
Also called precedex
dexmedetomidine intravenous infusion via syringe pump with loading dose of 0.5ug/kg over 5 minutes the continuous infusion in a dose of 0.2-0.7ug/kg/hour in addition to the propofol infusion as in propofol group
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | patients will receive only propofol intravenous infusion for sedation Receives: Drug: Propofol |
| propofol-dex. | Active comparator | patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation Receives: Drug: Propofol; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of sedation
to complete the procedure with diagnosis of site and degree of obstruction
Measured: the duration of the procedure under sedation is usually about 20 minutes
Secondary outcomes (1)
time until sufficient sedation
time till patient is ready to start endoscopy
Measured: about 5-10 minutes from start of sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start9 Apr 2017
- Primary completion8 Apr 2018
- Study completion8 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essam Fathi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Essam Fathi, Zagazig University
- Investigators
- essam f abdelgalel, A.professor, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091894
- Sponsor's protocol ID
- 3-2017-021
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03091894
- Acronym / sponsor ID
- 3-2017-021
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Dexmedetomidine, Sleep, Endoscopy, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Essam FathiOther government
- Study start
- 9 Apr 2017 (actual)
- Primary completion
- 8 Apr 2018 (actual)
- Study completion
- 8 Apr 2018 (actual)
- First posted
- 27 Mar 2017 (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.
This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.
Detailed description
Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: Propofolpatients will receive only propofol intravenous infusion for sedation |
| propofol-dex. | Active comparator | Drug: Propofol, Drug: Dexmedetomidinepatients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age more than 18 years
- patients with obstructive sleep apnea
- ASA 1and2
Key exclusion criteria (4 listed)
- patient refusal
- age less than 18 years
- morbid obesity
- known or suspected allergy to the studied drugs
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 |
|---|---|---|
| PropofolAlso: diprivanpropofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute | Drug | propofol, propofol-dex. |
| DexmedetomidineAlso: precedexdexmedetomidine intravenous infusion via syringe pump with loading dose of 0.5ug/kg over 5 minutes the continuous infusion in a dose of 0.2-0.7ug/kg/hour in addition to the propofol infusion as in propofol group | Drug | propofol-dex. |
Primary outcome
success of sedation
Time frame: the duration of the procedure under sedation is usually about 20 minutes
to complete the procedure with diagnosis of site and degree of obstruction
1 secondary outcome
time until sufficient sedation
Time frame: about 5-10 minutes from start of sedation
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 13 Apr 2018.
- 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.
essam f abdelgalel, A.professor principal investigator
Zagazig University
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 Propofol and Dexmedetomidine in people with Obstructive Sleep Apnea of Adult, run by Essam Fathi at 1 site in Egypt.
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 3 inclusion and 4 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 13 Apr 2018. 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 Egypt. 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.
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?
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?
success of sedation (time frame: the duration of the procedure under sedation is usually about 20 minutes). 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 13 Apr 2018.