Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome

Sleep Apnea, Obstructive Clinical Trial

— DESAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717780
• Other study ID #: CER 192/15
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Drug:
• Fentanyl and sevoflurane

• Remifentanil and desflurane

Locations

Country	Name	City	State
Switzerland	CHUV (Centre Hospitalier Universitaire Vaudois)	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position		postoperative night 1
Secondary	Number of obstructive apnea events		postoperative night 1 and night 3
Secondary	Percentage of time with saturation < 90%		postoperative night 1 and night 3
Secondary	Mean oxygen saturation		postoperative night 1 and night 3
Secondary	Total sleep duration		postoperative night 1 and night 3
Secondary	Percentage of time in supine position		postoperative night 1 and night 3
Secondary	Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position		postoperative night 1 and night 3
Secondary	Mean amplitude of desaturation (AD%)		postoperative night 1 and night 3
Secondary	Percentage of time in obstructive apnea		postoperative night 1 and night 3
Secondary	Percentage of time in central apnea		postoperative night 1 and night 3
Secondary	Percentage of time in mixt apnea		postoperative night 1 and night 3
Secondary	Sleep Apnea screening questionnaire (STOP BANG questionnaire)		24h before surgery
Secondary	Sleep Apnea screening questionnaire (Berlin questionnaire)		24h before surgery
Secondary	Sleep Apnea screening questionnaire (Epworth questionnaire)		24h before surgery
Secondary	Sleep Apnea screening questionnaire (NOSAS questionnaire)		24h before surgery
Secondary	Pain scores (numeric rating scale, 0-10)		postoperative day 0,1,2 and 3
Secondary	Postoperative nausea and vomiting (yes/no)		postoperative day 0,1,2 and 3
Secondary	Pruritus (yes/no)		postoperative day 0,1,2 and 3
Secondary	Opiate consumption (mg morphine)		postoperative day 0,1,2 and 3
Secondary	Level of satisfaction (visual analog scale)		postoperative day 3