Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome

Phase 4

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Interventions: Drug: Fentanyl and sevoflurane; Drug: Remifentanil and desflurane

• Registration Number: NCT02717780
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEVO-FENTA	Fentanyl and sevoflurane	Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane.
DES-REMI	Remifentanil and desflurane	Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane.

Primary Outcome Measures

Name	Time	Method
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position	postoperative night 1

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting (yes/no)	postoperative day 0,1,2 and 3
Percentage of time with saturation < 90%	postoperative night 1 and night 3
Percentage of time in obstructive apnea	postoperative night 1 and night 3
Sleep Apnea screening questionnaire (NOSAS questionnaire)	24h before surgery
Pain scores (numeric rating scale, 0-10)	postoperative day 0,1,2 and 3
Pruritus (yes/no)	postoperative day 0,1,2 and 3
Mean oxygen saturation	postoperative night 1 and night 3
Total sleep duration	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 mixt apnea	postoperative night 1 and night 3
Sleep Apnea screening questionnaire (Epworth questionnaire)	24h before surgery
Number of obstructive apnea events	postoperative night 1 and night 3
Percentage of time in supine position	postoperative night 1 and night 3
Percentage of time in central 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
Level of satisfaction (visual analog scale)	postoperative day 3
Opiate consumption (mg morphine)	postoperative day 0,1,2 and 3

Trial Locations

Locations (1)

CHUV (Centre Hospitalier Universitaire Vaudois); 🇨🇭 Lausanne, Vaud, Switzerland