Sleep Apnea SyndromesPhase 4DESATNCT02717780
Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome
A Phase 4 study testing Fentanyl and sevoflurane and Remifentanil and desflurane in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructive, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The investigators aim to assess the respiratory effect of short half-life agents in balanced anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus a regimen of fentanyl-sevoflurane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- What is being tested?
- Fentanyl and sevoflurane and Remifentanil and desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Jun 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
- Physical status I - III
- Patient scheduled to undergo lower limb orthopedic surgery
- Patients known for non-treated obstructive sleep apnea or suspected of having an obstructive sleep apnea
Who cannot join
- Patients known for treated obstructive sleep apnea ;
- Severe respiratory disease (i.e., chronic obstructive pulmonary disease, asthma, pulmonary fibrosis);
- Severe cardiovascular disease
- Chronic use of opiates ≥ 30mg/j morphine eq.
- Chronic use of benzodiazepine
- Inability to consent
- Refusal
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV (Centre Hospitalier Universitaire Vaudois)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Respiratory Impact of Short Life Agents Used in Balanced Anesthesia on Patients Suffering or Suspected of Obstructive Sleep Apnea (OSA) Syndrome
The investigators aim to assess the respiratory effect of short half-life agents in balanced anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory portable polygraphies: the night before the surgery ; the first night following the surgery ; the third night following the surgery.
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- Being tested
- Fentanyl and sevoflurane, Remifentanil and desflurane
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl and sevofluraneDrug
Remifentanil and desfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| SEVO-FENTA | Active comparator | Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane. Receives: Drug: Fentanyl and sevoflurane |
| DES-REMI | Experimental | Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane. Receives: Drug: Remifentanil and desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
Measured: postoperative night 1
Secondary outcomes (19)
Number of obstructive apnea events
Measured: postoperative night 1 and night 3
Percentage of time with saturation < 90%
Measured: postoperative night 1 and night 3
Mean oxygen saturation
Measured: postoperative night 1 and night 3
Total sleep duration
Measured: postoperative night 1 and night 3
Percentage of time in supine position
Measured: postoperative night 1 and night 3
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
Measured: postoperative night 1 and night 3
Mean amplitude of desaturation (AD%)
Measured: postoperative night 1 and night 3
Percentage of time in obstructive apnea
Measured: postoperative night 1 and night 3
Percentage of time in central apnea
Measured: postoperative night 1 and night 3
Percentage of time in mixt apnea
Measured: postoperative night 1 and night 3
Sleep Apnea screening questionnaire (STOP BANG questionnaire)
Measured: 24h before surgery
Sleep Apnea screening questionnaire (Berlin questionnaire)
Measured: 24h before surgery
Sleep Apnea screening questionnaire (Epworth questionnaire)
Measured: 24h before surgery
Sleep Apnea screening questionnaire (NOSAS questionnaire)
Measured: 24h before surgery
Pain scores (numeric rating scale, 0-10)
Measured: postoperative day 0,1,2 and 3
Postoperative nausea and vomiting (yes/no)
Measured: postoperative day 0,1,2 and 3
Pruritus (yes/no)
Measured: postoperative day 0,1,2 and 3
Opiate consumption (mg morphine)
Measured: postoperative day 0,1,2 and 3
Level of satisfaction (visual analog scale)
Measured: postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2018
- Study completionJun 2018
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 Apnea SyndromesStudies 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
- Prevention
- 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, PD, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717780
- Sponsor's protocol ID
- CER 192/15
- Acronym
- DESAT
- Status last verified
- Jul 2018
- First submitted
- 15 Mar 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Albrecht E, Wegrzyn J, Rossel JB, Bayon V, Heinzer R. Impact of spinal versus general anaesthesia on perioperative obstructive sleep apnoea severity in patients undergoing hip arthroplasty: a post hoc analysis of two randomised controlled trials. Br J Anaesth. 2024 Aug;133(2):416-423. doi: 10.1016/j.bja.2024.04.051. Epub 2024 Jun 10.
PubMed 38862381
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Impact of Short Life Agents Used in Balanced Anesthesia on Patients Suffering or Suspected of Obstructive Sleep Apnea (OSA) Syndrome
- ClinicalTrials.gov ID
- NCT02717780
- Acronym / sponsor ID
- DESAT / CER 192/15
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Mar 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 investigators aim to assess the respiratory effect of short half-life agents in balanced anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory portable polygraphies: the night before the surgery ; the first night following the surgery ; the third night following the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEVO-FENTA | Active comparator | Drug: Fentanyl and sevofluranePatients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane. |
| DES-REMI | Experimental | Drug: Remifentanil and desfluranePatients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physical status I - III
- Patient scheduled to undergo lower limb orthopedic surgery
- Patients known for non-treated obstructive sleep apnea or suspected of having an obstructive sleep apnea
Key exclusion criteria (7 listed)
- Patients known for treated obstructive sleep apnea ;
- Severe respiratory disease (i.e., chronic obstructive pulmonary disease, asthma, pulmonary fibrosis);
- Severe cardiovascular disease
- Chronic use of opiates ≥ 30mg/j morphine eq.
- Chronic use of benzodiazepine
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 |
|---|---|---|
| Fentanyl and sevoflurane | Drug | SEVO-FENTA |
| Remifentanil and desflurane | Drug | DES-REMI |
Primary outcome
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
Time frame: postoperative night 1
19 secondary outcomes
Number of obstructive apnea events
Time frame: postoperative night 1 and night 3
Percentage of time with saturation < 90%
Time frame: postoperative night 1 and night 3
Mean oxygen saturation
Time frame: postoperative night 1 and night 3
Total sleep duration
Time frame: postoperative night 1 and night 3
Percentage of time in supine position
Time frame: postoperative night 1 and night 3
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
Time frame: postoperative night 1 and night 3
Mean amplitude of desaturation (AD%)
Time frame: postoperative night 1 and night 3
Percentage of time in obstructive apnea
Time frame: postoperative night 1 and night 3
Percentage of time in central apnea
Time frame: postoperative night 1 and night 3
Percentage of time in mixt apnea
Time frame: postoperative night 1 and night 3
Sleep Apnea screening questionnaire (STOP BANG questionnaire)
Time frame: 24h before surgery
Sleep Apnea screening questionnaire (Berlin questionnaire)
Time frame: 24h before surgery
Sleep Apnea screening questionnaire (Epworth questionnaire)
Time frame: 24h before surgery
Sleep Apnea screening questionnaire (NOSAS questionnaire)
Time frame: 24h before surgery
Pain scores (numeric rating scale, 0-10)
Time frame: postoperative day 0,1,2 and 3
Postoperative nausea and vomiting (yes/no)
Time frame: postoperative day 0,1,2 and 3
Pruritus (yes/no)
Time frame: postoperative day 0,1,2 and 3
Opiate consumption (mg morphine)
Time frame: postoperative day 0,1,2 and 3
Level of satisfaction (visual analog scale)
Time frame: postoperative day 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 18 Jul 2018.
- Derived from this study: PubMed 38862381Albrecht E, Wegrzyn J, Rossel JB, Bayon V, Heinzer R. Impact of spinal versus general anaesthesia on perioperative obstructive sleep apnoea severity in patients undergoing hip arthroplasty: a post hoc analysis of two randomised controlled trials. Br J Anaesth. 2024 Aug;133(2):416-423. doi: 10.1016/j.bja.2024.04.051. Epub 2024 Jun 10.
- 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.
Eric Albrecht, PD, MD principal investigator
Centre Hospitalier Universitaire Vaudois
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 Fentanyl and sevoflurane and Remifentanil and desflurane in people with Sleep Apnea Syndromes and Sleep Apnea, Obstructive, 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 3 inclusion and 7 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 18 Jul 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 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?
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position (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 NCT02717780, 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 18 Jul 2018.