Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Respiratory Impact of Short Life Agents Used in Balanced Anesthesia on Patients Suffering or Suspected of Obstructive Sleep Apnea (OSA) Syndrome

Conditions
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Sleep Apnea Syndromes, Sleep Apnea, Obstructive

Intervention / Treatment
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* Drug: Fentanyl and sevoflurane
* Drug: Remifentanil and desflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SEVO-FENTA<br>Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane. | Drug: Fentanyl and sevoflurane<br> <br> |
| Experimental: DES-REMI<br>Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane. | Drug: Remifentanil and desflurane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position |  | postoperative night 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of obstructive apnea events |  | postoperative night 1 and night 3 | 
| 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 | 
| Sleep Apnea screening questionnaire (STOP BANG questionnaire) |  | 24h before surgery | 
| 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 |