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

Primary Purpose

Sleep Apnea Syndromes, Sleep Apnea, Obstructive

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Fentanyl and sevoflurane

Remifentanil and desflurane

About this trial

This is an interventional prevention trial for Sleep Apnea Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHUV (Centre Hospitalier Universitaire Vaudois)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SEVO-FENTA

DES-REMI

Arm Description

Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane.

Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of obstructive apnea events

Percentage of time with saturation < 90%

Mean oxygen saturation

Total sleep duration

Percentage of time in supine position

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

Mean amplitude of desaturation (AD%)

Percentage of time in obstructive apnea

Percentage of time in central apnea

Percentage of time in mixt apnea

Sleep Apnea screening questionnaire (STOP BANG questionnaire)

Sleep Apnea screening questionnaire (Berlin questionnaire)

Sleep Apnea screening questionnaire (Epworth questionnaire)

Sleep Apnea screening questionnaire (NOSAS questionnaire)

Pain scores (numeric rating scale, 0-10)

Postoperative nausea and vomiting (yes/no)

Pruritus (yes/no)

Opiate consumption (mg morphine)

Level of satisfaction (visual analog scale)

Full Information

NCT ID

NCT02717780

First Posted

March 15, 2016

Last Updated

July 17, 2018

Sponsor

Centre Hospitalier Universitaire Vaudois

1. Study Identification

Unique Protocol Identification Number

NCT02717780

Brief Title

Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome

Acronym

DESAT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea Syndromes, Sleep Apnea, Obstructive

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SEVO-FENTA

Arm Type

Active Comparator

Arm Description

Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane.

Arm Title

DES-REMI

Arm Type

Experimental

Arm Description

Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane.

Intervention Type

Drug

Intervention Name(s)

Fentanyl and sevoflurane

Intervention Type

Drug

Intervention Name(s)

Remifentanil and desflurane

Primary Outcome Measure Information:

Title

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

Time Frame

postoperative night 1

Secondary Outcome Measure Information:

Title

Number of obstructive apnea events

Time Frame