Obstructive Sleep ApneaNCT03499132
Influence of Different Anesthetic Procedures on Sleep Disorder Breathing
An observational study of Obstructive Sleep Apnea, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by partial or complete upper airway obstructions during sleep. OSA is associated with major comorbidities and perioperative complications. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2018to 1 Mar 2020
- Phase
- Observational
- 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 100 years
- All sexes
- Adult, Older adult
Study population: consecutive patients undergoing elective orthopedic surgery
Who may be able to join
- elective orthopedic surgery
Who cannot join
- already diagnosed sleep disorder breathing
- continuous positive airway pressure therapy
- tracheostomy
- American Society of Anesthesiologists class IV-V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Different Anesthetic Procedures on Sleep Disorder Breathing in Adult Patients Undergoing Elective Surgery
Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by partial or complete upper airway obstructions during sleep. OSA is associated with major comorbidities and perioperative complications. These complications are caused not only by the OSA itself, but also by exacerbations of this syndrome during the perioperative period (1). Benzodiazepines, volatile anesthetics and opioids may lead to lower hypoxia and hypercapnia sensitivity and may cause respiratory depression (2-5). Therefore, preference of neuraxial blockades and avoidance of opioids has been suggested for patients with OSA (6). However, there is still lack of evidence to evaluate the effects of various anesthesia procedures on OSA (6,7). We hypothesize different anesthetic procedures will have different effect on OSA exacerbations in the postoperative period. Accordingly, the aim of this study is to compare the number of sleep disordered breathing episodes in the postoperative period in patients with different anesthetic procedures.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- anesthesia
- Keywords
- anesthesia, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesiaProcedure or surgery
Different anesthetic procedures
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia (with opioids) | orthopedic surgery plus general anesthesia Receives: Procedure: anesthesia | |
| Epidural anesthesia (without opioids) | orthopedic surgery plus epidural anesthesia (without opioids use) Receives: Procedure: anesthesia | |
| Subarachnoid anesthesia (with opioids) | orthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid) Receives: Procedure: anesthesia | |
| Regional anesthesia (without opioids) | orthopedic surgery plus regional anesthesia (peripheral nerve block, continous or single shot, without opioid use) Receives: Procedure: anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index change
Changes (post-pre) in apnea-hypopnea index 4 nights post surgery
Measured: 4 nights after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic
- Investigators
- Ivan Cundrle, M.D., Ph.D., Principal investigator, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499132
- Sponsor's protocol ID
- IIT/2017/30
- Status last verified
- Mar 2020
- First submitted
- 8 Apr 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041.
PubMed 24158050Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.
PubMed 3354874Weil JV, McCullough RE, Kline JS, Sodal IE. Diminished ventilatory response to hypoxia and hypercapnia after morphine in normal man. N Engl J Med. 1975 May 22;292(21):1103-6. doi: 10.1056/NEJM197505222922106.
PubMed 1128555Dahan A, van den Elsen MJ, Berkenbosch A, DeGoede J, Olievier IC, van Kleef JW, Bovill JG. Effects of subanesthetic halothane on the ventilatory responses to hypercapnia and acute hypoxia in healthy volunteers. Anesthesiology. 1994 Apr;80(4):727-38. doi: 10.1097/00000542-199404000-00004.
PubMed 8024126van den Elsen M, Dahan A, DeGoede J, Berkenbosch A, van Kleef J. Influences of subanesthetic isoflurane on ventilatory control in humans. Anesthesiology. 1995 Sep;83(3):478-90. doi: 10.1097/00000542-199509000-00006.
PubMed 7661348American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
PubMed 24346178Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765.
PubMed 29300271
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Anesthetic Procedures on Sleep Disorder Breathing in Adult Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT03499132
- Acronym / sponsor ID
- IIT/2017/30
- Conditions
- Obstructive Sleep Apnea
- Keywords
- anesthesia, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Apr 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.
Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by partial or complete upper airway obstructions during sleep. OSA is associated with major comorbidities and perioperative complications. These complications are caused not only by the OSA itself, but also by exacerbations of this syndrome during the perioperative period (1). Benzodiazepines, volatile anesthetics and opioids may lead to lower hypoxia and hypercapnia sensitivity and may cause respiratory depression (2-5). Therefore, preference of neuraxial blockades and avoidance of opioids has been suggested for patients with OSA (6). However, there is still lack of evidence to evaluate the effects of various anesthesia procedures on OSA (6,7). We hypothesize different anesthetic procedures will have different effect on OSA exacerbations in the postoperative period. Accordingly, the aim of this study is to compare the number of sleep disordered breathing episodes in the postoperative period in patients with different anesthetic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General anesthesia (with opioids) | – | Procedure: anesthesiaorthopedic surgery plus general anesthesia |
| Epidural anesthesia (without opioids) | – | Procedure: anesthesiaorthopedic surgery plus epidural anesthesia (without opioids use) |
| Subarachnoid anesthesia (with opioids) | – | Procedure: anesthesiaorthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid) |
| Regional anesthesia (without opioids) | – | Procedure: anesthesiaorthopedic surgery plus regional anesthesia (peripheral nerve block, continous or single shot, without opioid use) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing elective orthopedic surgery
Key inclusion criteria (1 listed)
- elective orthopedic surgery
Key exclusion criteria (4 listed)
- already diagnosed sleep disorder breathing
- continuous positive airway pressure therapy
- tracheostomy
- American Society of Anesthesiologists class IV-V
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 |
|---|---|---|
| anesthesiaDifferent anesthetic procedures | Procedure or surgery | Epidural anesthesia (without opioids), General anesthesia (with opioids), Regional anesthesia (without opioids), Subarachnoid anesthesia (with opioids) |
Primary outcome
Apnea-hypopnea index change
Time frame: 4 nights after surgery
Changes (post-pre) in apnea-hypopnea index 4 nights post surgery
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 17 Mar 2020.
- Background: PubMed 24158050Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041.
- Background: PubMed 3354874Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.
- Background: PubMed 1128555Weil JV, McCullough RE, Kline JS, Sodal IE. Diminished ventilatory response to hypoxia and hypercapnia after morphine in normal man. N Engl J Med. 1975 May 22;292(21):1103-6. doi: 10.1056/NEJM197505222922106.
- Background: PubMed 8024126Dahan A, van den Elsen MJ, Berkenbosch A, DeGoede J, Olievier IC, van Kleef JW, Bovill JG. Effects of subanesthetic halothane on the ventilatory responses to hypercapnia and acute hypoxia in healthy volunteers. Anesthesiology. 1994 Apr;80(4):727-38. doi: 10.1097/00000542-199404000-00004.
- Background: PubMed 7661348van den Elsen M, Dahan A, DeGoede J, Berkenbosch A, van Kleef J. Influences of subanesthetic isoflurane on ventilatory control in humans. Anesthesiology. 1995 Sep;83(3):478-90. doi: 10.1097/00000542-199509000-00006.
- Background: PubMed 24346178American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
- Background: PubMed 29300271Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765.
- 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.
Ivan Cundrle, M.D., Ph.D. principal investigator
St. Anne's University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 17 Mar 2020. 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 Czechia. 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.
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 change (time frame: 4 nights after surgery). 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 NCT03499132, which also lists 7 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 17 Mar 2020.