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Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome (DESAT)

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ClinicalTrials.gov Identifier: NCT02717780
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Sleep Apnea, Obstructive Drug: Fentanyl and sevoflurane Drug: Remifentanil and desflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Respiratory Impact of Short Life Agents Used in Balanced Anesthesia on Patients Suffering or Suspected of Obstructive Sleep Apnea (OSA) Syndrome
Study Start Date : February 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  1. Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position [ Time Frame: postoperative night 1 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717780


Locations
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Switzerland
CHUV (Centre Hospitalier Universitaire Vaudois)
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Eric Albrecht, PD, MD Centre Hospitalier Universitaire Vaudois

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Responsible Party: Eric Albrecht, PD Dr, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02717780     History of Changes
Other Study ID Numbers: CER 192/15
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fentanyl
Remifentanil
Anesthetics
Sevoflurane
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors