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Completed

NCT Number: NCT02717780

Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea 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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHUV (Centre Hospitalier Universitaire Vaudois)

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl and sevoflurane

Drug

Remifentanil and Desflurane

Drug

Primary outcomes

  1. Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position

    Time frame: postoperative night 1

Secondary outcomes

  1. Number of obstructive apnea events

    Time frame: postoperative night 1 and night 3

  2. Percentage of time with saturation < 90%

    Time frame: postoperative night 1 and night 3

  3. Mean oxygen saturation

    Time frame: postoperative night 1 and night 3

  4. Total sleep duration

    Time frame: postoperative night 1 and night 3

  5. Percentage of time in supine position

    Time frame: postoperative night 1 and night 3

  6. Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position

    Time frame: postoperative night 1 and night 3

  7. Mean amplitude of desaturation (AD%)

    Time frame: postoperative night 1 and night 3

  8. Percentage of time in obstructive apnea

    Time frame: postoperative night 1 and night 3

  9. Percentage of time in central apnea

    Time frame: postoperative night 1 and night 3

  10. Percentage of time in mixt apnea

    Time frame: postoperative night 1 and night 3

  11. Sleep Apnea screening questionnaire (STOP BANG questionnaire)

    Time frame: 24h before surgery

  12. Sleep Apnea screening questionnaire (Berlin questionnaire)

    Time frame: 24h before surgery

  13. Sleep Apnea screening questionnaire (Epworth questionnaire)

    Time frame: 24h before surgery

  14. Sleep Apnea screening questionnaire (NOSAS questionnaire)

    Time frame: 24h before surgery

  15. Pain scores (numeric rating scale, 0-10)

    Time frame: postoperative day 0,1,2 and 3

  16. Postoperative nausea and vomiting (yes/no)

    Time frame: postoperative day 0,1,2 and 3

  17. Pruritus (yes/no)

    Time frame: postoperative day 0,1,2 and 3

  18. Opiate consumption (mg morphine)

    Time frame: postoperative day 0,1,2 and 3

  19. Level of satisfaction (visual analog scale)

    Time frame: postoperative day 3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: DESAT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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