Short Life Agents in Balanced Anesthesia on Obstructive Sleep Apnea Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea Syndromes Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SEVO-FENTA

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

Group Type ACTIVE_COMPARATOR

Fentanyl and sevoflurane

Intervention Type DRUG

DES-REMI

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

Group Type EXPERIMENTAL

Remifentanil and desflurane

Intervention Type DRUG

Interventions

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Fentanyl and sevoflurane

Intervention Type DRUG

Remifentanil and desflurane

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No