Abnormal Respiratory Airway ResistancePhase 4NCT02330120
Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics
A Phase 4 study testing propofol and dexmedetomidine in people with Abnormal Respiratory Airway Resistance, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Abnormal Respiratory Airway Resistance
- 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
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Aug 2015
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients mechanically ventilated in intensive care unit
Who cannot join
- Patients with contraindications for using propofol and dexmedetomidine
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients.
Read the detailed description
The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this study. Patients are divided into two random groups, Group P (propofol) and Group D (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP, cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded. This parameters are evaluated with Drager Evita 4 ventilator and recorded on 5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and recorded.
The primary outcome measures are airway resistance and peak airway pressure. Secondary outcome measure is sedation score.
- Conditions
- Abnormal Respiratory Airway Resistance
- Being tested
- propofol, dexmedetomidine
- Keywords
- peak airway pressure, airway resistance, sedation, intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
dexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Propofol infusion 0.5-2 mg/kg/h for sedation in mechanically ventilated patients Receives: Drug: propofol |
| dexmedetomidine | Active comparator | dexmedetomidine infusion 0.2-0.7 mcg/kg/h for sedation in mechanically ventilated patients Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway resistance
airway resistans measured by Evita 4 ventilator flow sensor
Measured: 60 minutes
peak airway pressure values
peak airway pressure values provide the methods used to Evita 4 ventilator flow sensor
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abnormal Respiratory Airway ResistanceStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mediha turktan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330120
- Sponsor's protocol ID
- intensive care
- Status last verified
- Dec 2015
- First submitted
- 17 Nov 2014
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandes FC, Ferreira HC, Cagido VR, Carvalho GM, Pereira LS, Faffe DS, Zin WA, Rocco PR. Effects of dexmedetomidine on respiratory mechanics and control of breathing in normal rats. Respir Physiol Neurobiol. 2006 Dec;154(3):342-50. doi: 10.1016/j.resp.2006.02.002. Epub 2006 Mar 9.
PubMed 16527548Bang SR, Lee SE, Ahn HJ, Kim JA, Shin BS, Roe HJ, Sim WS. Comparison of respiratory mechanics between sevoflurane and propofol-remifentanil anesthesia for laparoscopic colectomy. Korean J Anesthesiol. 2014 Feb;66(2):131-5. doi: 10.4097/kjae.2014.66.2.131. Epub 2014 Feb 28.
PubMed 24624271
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics
- ClinicalTrials.gov ID
- NCT02330120
- Acronym / sponsor ID
- intensive care
- Conditions
- Abnormal Respiratory Airway Resistance
- Keywords
- peak airway pressure, airway resistance, sedation, intensive care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Jan 2015 (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 aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients.
Detailed description
The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this study. Patients are divided into two random groups, Group P (propofol) and Group D (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP, cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded. This parameters are evaluated with Drager Evita 4 ventilator and recorded on 5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and recorded.
The primary outcome measures are airway resistance and peak airway pressure. Secondary outcome measure is sedation score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Drug: propofolPropofol infusion 0.5-2 mg/kg/h for sedation in mechanically ventilated patients |
| dexmedetomidine | Active comparator | Drug: dexmedetomidinedexmedetomidine infusion 0.2-0.7 mcg/kg/h for sedation in mechanically ventilated patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients mechanically ventilated in intensive care unit
Key exclusion criteria (1 listed)
- Patients with contraindications for using propofol and dexmedetomidine
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 |
|---|---|---|
| propofol | Drug | propofol |
| dexmedetomidine | Drug | dexmedetomidine |
Primary outcome
airway resistance
Time frame: 60 minutes
airway resistans measured by Evita 4 ventilator flow sensor
peak airway pressure values
Time frame: 60 minutes
peak airway pressure values provide the methods used to Evita 4 ventilator flow sensor
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 10 Dec 2015.
- Background: PubMed 16527548Fernandes FC, Ferreira HC, Cagido VR, Carvalho GM, Pereira LS, Faffe DS, Zin WA, Rocco PR. Effects of dexmedetomidine on respiratory mechanics and control of breathing in normal rats. Respir Physiol Neurobiol. 2006 Dec;154(3):342-50. doi: 10.1016/j.resp.2006.02.002. Epub 2006 Mar 9.
- Background: PubMed 24624271Bang SR, Lee SE, Ahn HJ, Kim JA, Shin BS, Roe HJ, Sim WS. Comparison of respiratory mechanics between sevoflurane and propofol-remifentanil anesthesia for laparoscopic colectomy. Korean J Anesthesiol. 2014 Feb;66(2):131-5. doi: 10.4097/kjae.2014.66.2.131. Epub 2014 Feb 28.
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?
A Phase 4 study testing propofol and dexmedetomidine in people with Abnormal Respiratory Airway Resistance, run by Cukurova University at 1 site in Turkey (Türkiye).
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 10 Dec 2015. 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 Turkey (Türkiye). 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?
airway resistance (time frame: 60 minutes). 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 NCT02330120, which also lists 2 linked publications.
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 10 Dec 2015.