Clinical trial NCT02717780: Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome
Official title: Respiratory Impact of Short Life Agents Used in Balanced Anesthesia on Patients Suffering or Suspected of Obstructive Sleep Apnea (OSA) Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
timeFrame: postoperative night 1
Secondary outcomes:
measure: Number of obstructive apnea events
timeFrame: postoperative night 1 and night 3
measure: Percentage of time with saturation < 90%
timeFrame: postoperative night 1 and night 3
measure: Mean oxygen saturation
timeFrame: postoperative night 1 and night 3
measure: Total sleep duration
timeFrame: postoperative night 1 and night 3
measure: Percentage of time in supine position
timeFrame: postoperative night 1 and night 3
measure: Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
timeFrame: postoperative night 1 and night 3
measure: Mean amplitude of desaturation (AD%)
timeFrame: postoperative night 1 and night 3
measure: Percentage of time in obstructive apnea
timeFrame: postoperative night 1 and night 3
measure: Percentage of time in central apnea
timeFrame: postoperative night 1 and night 3
measure: Percentage of time in mixt apnea
timeFrame: postoperative night 1 and night 3
measure: Sleep Apnea screening questionnaire (STOP BANG questionnaire)
timeFrame: 24h before surgery
measure: Sleep Apnea screening questionnaire (Berlin questionnaire)
timeFrame: 24h before surgery
measure: Sleep Apnea screening questionnaire (Epworth questionnaire)
timeFrame: 24h before surgery
measure: Sleep Apnea screening questionnaire (NOSAS questionnaire)
timeFrame: 24h before surgery
measure: Pain scores (numeric rating scale, 0-10)
timeFrame: postoperative day 0,1,2 and 3
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: postoperative day 0,1,2 and 3
measure: Pruritus (yes/no)
timeFrame: postoperative day 0,1,2 and 3
measure: Opiate consumption (mg morphine)
timeFrame: postoperative day 0,1,2 and 3
measure: Level of satisfaction (visual analog scale)
timeFrame: postoperative day 3
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV (Centre Hospitalier Universitaire Vaudois)
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Albrecht, PD, MD
role: PRINCIPAL_INVESTIGATOR
References: