Restrictive Lung DiseasePhase 4NCT02843698
Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Restrictive Lung Disease, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Restrictive Lung Disease
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to 26 Aug 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbid obese (body mass index > 40) with documented restrictive lung disease scheduled to bariatric operation.
Who cannot join
- Heart failure
- ِِِِArrhythmia
- Heart block
- Severe liver or kidney impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial
The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients
Read the detailed description
The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively
- Conditions
- Restrictive Lung Disease
- Being tested
- Dexmedetomidine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine infusion was previously reported to improve oxygenation and lung dynamics in patients with obstructive lung diseases. In our study we are going to investigate its effect on oxygenation and lung dynamics in restrictive lung disease
Normal salineDrug
Also called Saline
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Patients will receive either, Dexmedetomidine (Precedex, Hospira, Lake forest, IL, USA) in a dose of (1ug/Kg LBW) bolus followed by 0.5ug/Kg continuous infusion for one hour Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | Patients will receive normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
assessed by P/F ratio
Measured: 2 hours
Secondary outcomes (4)
Lung mechanics
lung compliance and dead space
Measured: 2 hours
arterial blood pressure
arterial blood pressure measured in mmHg
Measured: 2 hours
plateau airway pressure
plateau airway pressure measured in cmH2o
Measured: 2 hours
heart rate
number of heart beats per minute
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion26 Aug 2017
- Study completion26 Aug 2017
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 Restrictive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843698
- Sponsor's protocol ID
- N-12-2016
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y.
PubMed 30103679
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02843698
- Acronym / sponsor ID
- N-12-2016
- Conditions
- Restrictive Lung Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 26 Aug 2017 (actual)
- Study completion
- 26 Aug 2017 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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 aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients
Detailed description
The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients will receive either, Dexmedetomidine (Precedex, Hospira, Lake forest, IL, USA) in a dose of (1ug/Kg LBW) bolus followed by 0.5ug/Kg continuous infusion for one hour |
| Control group | Placebo comparator | Drug: Normal salinePatients will receive normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Morbid obese (body mass index > 40) with documented restrictive lung disease scheduled to bariatric operation.
Key exclusion criteria (4 listed)
- Heart failure
- ِِِِArrhythmia
- Heart block
- Severe liver or kidney impairment.
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine infusion was previously reported to improve oxygenation and lung dynamics in patients with obstructive lung diseases. In our study we are going to investigate its effect on oxygenation and lung dynamics in restrictive lung disease | Drug | Dexmedetomidine group |
| Normal salineAlso: SalineNormal saline | Drug | Control group |
Primary outcome
Oxygenation
Time frame: 2 hours
assessed by P/F ratio
4 secondary outcomes
Lung mechanics
Time frame: 2 hours
arterial blood pressure
Time frame: 2 hours
plateau airway pressure
Time frame: 2 hours
heart rate
Time frame: 2 hours
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 29 Aug 2017.
- Derived from this study: PubMed 30103679Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y.
- 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.
Ahmed Mukhtar, Professor study director
Head of research committee section in anesthesia department
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 Normal saline in people with Restrictive Lung Disease, run by Cairo University 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 1 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 29 Aug 2017. 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. 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?
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?
Oxygenation (time frame: 2 hours). 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 NCT02843698, 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 29 Aug 2017.