Sleep ApneaPhase 4TROXATNCT03454217
Impact of Tramadol and Oxycodone on Sleep Apnea
A Phase 4 study testing Oxycodone and Tramadol in people with Sleep Apnea, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Oxycodone and Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2018to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
- physical status I-III
Who cannot join
- planned surgical duration more than 3 hours
- contraindication to spinal anaesthesia
- severe respiratory disease
- patient treated for sleep apnea syndrome
- allergy to tramadol or oxycodone
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
About this study
Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.
- Conditions
- Sleep Apnea
- Being tested
- Oxycodone, Tramadol
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Postoperative pain treatment with oxycodone
TramadolDrug
Postoperative pain treatment with tramadol
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Active comparator | Postoperative pain treatment with oxycodone Receives: Drug: Oxycodone |
| Tramadol | Active comparator | Postoperative pain treatment with tramadol Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index while lying supine
Apnea hypopnea index while lying supine
Measured: Postoperative night 1
Secondary outcomes (7)
Apnea hypopnea index in another position than supine
Measured: Postoperative night 1
Mean pulse oxymetry
Measured: Postoperative night 1
Apnea hypopnea index while lying supine
Measured: Postoperative night 3
Apnea hypopnea index in another position than supine
Measured: Postoperative night 3
Mean pulse oxymetry
Measured: Postoperative night 3
Pains scores (numeric rating scale)
Measured: Postoperative day 0, 1, 2 and 3
Opioid (oxycodone or tramadol) consumption
Measured: Postoperative day 0, 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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 Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454217
- Sponsor's protocol ID
- CER 2017-01976
- Acronym
- TROXAT
- Status last verified
- Jan 2021
- First submitted
- 27 Feb 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon request
Publications
Albrecht E, Pereira P, Bayon V, Berger M, Wegrzyn J, Antoniadis A, Heinzer R. The Relationship Between Postoperative Opioid Analgesia and Sleep Apnea Severity in Patients Undergoing Hip Arthroplasty: A Randomized, Controlled, Triple-Blinded Trial. Nat Sci Sleep. 2022 Feb 25;14:303-310. doi: 10.2147/NSS.S348834. eCollection 2022.
PubMed 35241942
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tramadol and Oxycodone on Sleep Apnea
- ClinicalTrials.gov ID
- NCT03454217
- Acronym / sponsor ID
- TROXAT / CER 2017-01976
- Conditions
- Sleep Apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Mar 2018 (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.
Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Active comparator | Drug: OxycodonePostoperative pain treatment with oxycodone |
| Tramadol | Active comparator | Drug: TramadolPostoperative pain treatment with tramadol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
- physical status I-III
Key exclusion criteria (5 listed)
- planned surgical duration more than 3 hours
- contraindication to spinal anaesthesia
- severe respiratory disease
- patient treated for sleep apnea syndrome
- allergy to tramadol or oxycodone
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 |
|---|---|---|
| OxycodonePostoperative pain treatment with oxycodone | Drug | Oxycodone |
| TramadolPostoperative pain treatment with tramadol | Drug | Tramadol |
Primary outcome
Apnea hypopnea index while lying supine
Time frame: Postoperative night 1
Apnea hypopnea index while lying supine
7 secondary outcomes
Apnea hypopnea index in another position than supine
Time frame: Postoperative night 1
Mean pulse oxymetry
Time frame: Postoperative night 1
Apnea hypopnea index while lying supine
Time frame: Postoperative night 3
Apnea hypopnea index in another position than supine
Time frame: Postoperative night 3
Mean pulse oxymetry
Time frame: Postoperative night 3
Pains scores (numeric rating scale)
Time frame: Postoperative day 0, 1, 2 and 3
Opioid (oxycodone or tramadol) consumption
Time frame: Postoperative day 0, 1, 2 and 3
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 27 Jan 2021.
- Derived from this study: PubMed 35241942Albrecht E, Pereira P, Bayon V, Berger M, Wegrzyn J, Antoniadis A, Heinzer R. The Relationship Between Postoperative Opioid Analgesia and Sleep Apnea Severity in Patients Undergoing Hip Arthroplasty: A Randomized, Controlled, Triple-Blinded Trial. Nat Sci Sleep. 2022 Feb 25;14:303-310. doi: 10.2147/NSS.S348834. eCollection 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
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.
Eric Albrecht principal investigator
University of Lausanne Hospitals
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 Oxycodone and Tramadol in people with Sleep Apnea, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 inclusion and 5 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 27 Jan 2021. 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 Switzerland. 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?
Apnea hypopnea index while lying supine (time frame: Postoperative night 1). 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 NCT03454217, 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 27 Jan 2021.