Sleep Apnea, Obstructive, Sleep Apnea Syndromes
Conditions
Brief 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. 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.
Interventions
DRUGFentanyl and sevoflurane
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position | postoperative night 1 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of time with saturation < 90% | postoperative night 1 and night 3 |
| Mean oxygen saturation | postoperative night 1 and night 3 |
| Total sleep duration | postoperative night 1 and night 3 |
| Percentage of time in supine position | postoperative night 1 and night 3 |
| Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position | postoperative night 1 and night 3 |
| Mean amplitude of desaturation (AD%) | postoperative night 1 and night 3 |
| Percentage of time in obstructive apnea | postoperative night 1 and night 3 |
| Percentage of time in central apnea | postoperative night 1 and night 3 |
| Percentage of time in mixt apnea | postoperative night 1 and night 3 |
| Number of obstructive apnea events | postoperative night 1 and night 3 |
| Sleep Apnea screening questionnaire (Berlin questionnaire) | 24h before surgery |
| Sleep Apnea screening questionnaire (Epworth questionnaire) | 24h before surgery |
| Sleep Apnea screening questionnaire (NOSAS questionnaire) | 24h before surgery |
| Pain scores (numeric rating scale, 0-10) | postoperative day 0,1,2 and 3 |
| Postoperative nausea and vomiting (yes/no) | postoperative day 0,1,2 and 3 |
| Pruritus (yes/no) | postoperative day 0,1,2 and 3 |
| Opiate consumption (mg morphine) | postoperative day 0,1,2 and 3 |
| Level of satisfaction (visual analog scale) | postoperative day 3 |
| Sleep Apnea screening questionnaire (STOP BANG questionnaire) | 24h before surgery |
Countries
Switzerland
Outcome results
None listed