NCT02717780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

March 15, 2016

Last Update Submit

July 17, 2018

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

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

    postoperative night 1

Secondary Outcomes (19)

  • Number of obstructive apnea events

    postoperative night 1 and night 3

  • Percentage of time with saturation < 90%

    postoperative night 1 and night 3

  • Mean oxygen saturation

    postoperative night 1 and night 3

  • Total sleep duration

    postoperative night 1 and night 3

  • Percentage of time in supine position

    postoperative night 1 and night 3

  • +14 more secondary outcomes

Study Arms (2)

SEVO-FENTA

ACTIVE COMPARATOR

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

Drug: Fentanyl and sevoflurane

DES-REMI

EXPERIMENTAL

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

Drug: Remifentanil and desflurane

Interventions

Fentanyl and sevofluraneDRUG
SEVO-FENTA
Remifentanil and desfluraneDRUG
DES-REMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV (Centre Hospitalier Universitaire Vaudois)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • Albrecht E, Wegrzyn J, Rossel JB, Bayon V, Heinzer R. Impact of spinal versus general anaesthesia on perioperative obstructive sleep apnoea severity in patients undergoing hip arthroplasty: a post hoc analysis of two randomised controlled trials. Br J Anaesth. 2024 Aug;133(2):416-423. doi: 10.1016/j.bja.2024.04.051. Epub 2024 Jun 10.

    PMID: 38862381DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Interventions

FentanylSevofluraneRemifentanilDesflurane

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPropionatesAcids, AcyclicCarboxylic AcidsEthyl Ethers

Study Officials

  • Eric Albrecht, PD, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 24, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)