HypoxiaPhase 4NCT01873612
Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
A Phase 4 study testing Hypoxic ventilatory response and Hypercapnic ventilatory response in people with Hypoxia and Anesthetics, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Anesthetics, Conscious Sedation
- What is being tested?
- Hypoxic ventilatory response and Hypercapnic ventilatory response
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- May 2013to Sep 2014
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18-40
- American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
- No medication
- No allergies
- Non-smoker/no snuff, i.e. no nicotine intake
- Normal weight, BMI <26
Who cannot join
- Snoring
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Stockholm, SE-17176
About this study
The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.
Read the detailed description
15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study.
6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.
- Conditions
- Hypoxia, Anesthetics, Conscious Sedation, Hypercapnia
- Being tested
- Hypoxic ventilatory response, Hypercapnic ventilatory response
- Keywords
- Dexmedetomidine, Propofol, Hypoxic ventilatory response, Hypercapnic ventilatory response
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic ventilatory responseProcedure or surgery
Also called HVR
Hypercapnic ventilatory responseProcedure or surgery
Also called HCVR
| Study group | Role | What they receive |
|---|---|---|
| Sedation with dexmedetomidine | Experimental | Sedation with dexmedetomidine Receives: Procedure: Hypoxic ventilatory response; Procedure: Hypercapnic ventilatory response |
| Sedation with propofol | Experimental | Sedation with propofol Receives: Procedure: Hypoxic ventilatory response; Procedure: Hypercapnic ventilatory response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxic ventilatory response
Acute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation
Measured: One day for each drug; before,during and after sedation with dexmeditomidine or propofol
Secondary outcomes (1)
hypercapnic ventilatory response
The acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide
Measured: One day for each drug; Before, during and after sedation with dexmedetomidine or propofol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, MD, PhD, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873612
- Sponsor's protocol ID
- PropDexHVRVolunteers
- Status last verified
- Feb 2016
- First submitted
- 29 May 2013
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01873612
- Acronym / sponsor ID
- PropDexHVRVolunteers
- Conditions
- Hypoxia, Anesthetics, Conscious Sedation, Hypercapnia
- Keywords
- Dexmedetomidine, Propofol, Hypoxic ventilatory response, Hypercapnic ventilatory response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jun 2013 (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 overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.
Detailed description
15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study.
6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation with dexmedetomidine | Experimental | Procedure: Hypoxic ventilatory response, Procedure: Hypercapnic ventilatory responseSedation with dexmedetomidine |
| Sedation with propofol | Experimental | Procedure: Hypoxic ventilatory response, Procedure: Hypercapnic ventilatory responseSedation with propofol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Age 18-40
- American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
- No medication
- No allergies
Key exclusion criteria (1 listed)
- Snoring
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 |
|---|---|---|
| Hypoxic ventilatory responseAlso: HVR | Procedure or surgery | Sedation with dexmedetomidine, Sedation with propofol |
| Hypercapnic ventilatory responseAlso: HCVR | Procedure or surgery | Sedation with dexmedetomidine, Sedation with propofol |
Primary outcome
Hypoxic ventilatory response
Time frame: One day for each drug; before,during and after sedation with dexmeditomidine or propofol
Acute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation
1 secondary outcome
hypercapnic ventilatory response
Time frame: One day for each drug; Before, during and after sedation with dexmedetomidine or propofol
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 26 Feb 2016.
Related trials for Hypoxia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
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.
Malin Jonsson Fagerlund, MD, PhD principal investigator
Karolinska University Hospital and Karolinska Institutet
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 Hypoxic ventilatory response and Hypercapnic ventilatory response in people with Hypoxia and Anesthetics, run by Karolinska University Hospital at 1 site in Sweden.
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 7 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 26 Feb 2016. 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 Sweden. 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?
Hypoxic ventilatory response (time frame: One day for each drug; before,during and after sedation with dexmeditomidine or propofol). 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 26 Feb 2016.