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

V

Vaud University Hospital Center

Status and phase

Completed
Phase 4

Conditions

Sleep Apnea Syndromes
Sleep Apnea, Obstructive

Treatments

Drug: Fentanyl and sevoflurane
Drug: Remifentanil and desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT02717780
CER 192/15

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

SEVO-FENTA
Active Comparator group
Description:
Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane.
Treatment:
Drug: Fentanyl and sevoflurane
DES-REMI
Experimental group
Description:
Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane.
Treatment:
Drug: Remifentanil and desflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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