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

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Intervention / Treatment: Drug: Fentanyl and sevoflurane; Drug: Remifentanil and desflurane

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV (centre hospitalier universitaire vaudois)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Eric Albrecht, PD, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (ESTIMATE): March 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Inhalation; Remifentanil; Fentanyl; Desflurane; Sevoflurane
• Other Study ID Numbers: CER 192/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO