Clinical Predictors of Apnea-hypopnea During Propofol Sedation (sleeposa)
5. juni 2013 opdateret af: Jeong Jin Lee, Samsung Medical Center
Clinical Predictors of Apnea-hypopnea During Propofol Sedation in Patients Undergoing Spinal Anaesthesia
To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under spinal anaesthesia will be enrolled.
Before surgery, patients will be asked to complete a STOP-questionnaire.
The eRDI will be calculated using the modified Mallampati's grade, tonsil grade, and the body mass index.
After performing spinal anaesthesia, propofol will be infused and adjusted to BIS 70-75.
An ApneaLinkTM, which measures airflow through a nasal cannula, will be then applied to estimate the level of apnea-hypopnea.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The investigators will evaluate correlation between STOP scor and AHI(apnea hypopnea index) or eRDI and AHI.
After then the investigators will compare AHI severity between high risk group and low risk group subgrouped according to STOP score or eRDI.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
29
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
We expected a correlation coefficient of ~0.5 in this study, which meant that for a level of significance of 5% and a power of 80%, we required 29 analyzable subjects.
Based on a predicted exclusion rate of 15%, 34 patients were included.
Beskrivelse
Inclusion Criteria:
- Thirty four males who underwent spinal anaesthesia for transurethral resection of the bladder (TURB) or prostate (TURP) were enrolled in this studyInclusion criteria were American Society of Anaesthesiologists (ASA) physical status of 1-2, and ages of more than 40 years.
Exclusion Criteria:
- Patients with electrocardiographic or simple chest radiographic abnormalities or who had taken medication that could affect their sleep patterns were excluded.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Apnea hypopnea index
Tidsramme: 1hour
|
After surgery, an ApneaLinkTM was connected to a personal computer to record and auto-analyze AHIs.
Aopnea was defined as a cessation of airflow for 10s or longer.
Hypopnea was defined as a greater than 50% reduction in airflow for 10s or longer.
AHI was defined as the number of aopnea and hypopnea incidents per hour.
|
1hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jeong Jin Lee, Professor, : Department of Anaesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2008
Primær færdiggørelse (Faktiske)
1. november 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
4. juni 2013
Først indsendt, der opfyldte QC-kriterier
5. juni 2013
Først opslået (Skøn)
6. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- sleeposa
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