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Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

24. juli 2012 opdateret af: Diana L Fernandez Galinski, Hospital de Sabadell

Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or L bupivacaine (dose 7 - 9 mg). Preoperative haemoglobin and drugs consumption are registered. All patients receive supplemental oxygen during surgery. Cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. Level and duration of sensory and motor block are registered. The study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters.

The investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by SPMSQ test.

Postoperative SPMSQ test will be performed on the 5th postoperative day and the complications registered.Patients will be followed for the duration of acute hospital stay.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Sabadell
      • Barcelona, Sabadell, Spanien, 08208
        • Rekruttering
        • Hospital de Sabadell - CSPT
        • Kontakt:
        • Kontakt:
          • Francisca Gordo Lacal, Dr
          • Telefonnummer: 21277 0034937231010
          • E-mail: fgordo@tauli.cat
        • Ledende efterforsker:
          • Diana L Fernández Galinski, PhD

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

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged > 70 years old with hip fracture undergoing surgery under spinal anaesthesia.

Beskrivelse

Inclusion criteria:

  • Patients aged >70 years old with hip fracture.
  • No contraindication for spinal anaesthesia.

Exclusion Criteria:

  • Allergic reaction to local anesthetics.
  • Severe aortic stenosis.
  • Local infection.
  • SPMSQ test >7 errors.
  • Patient refusal

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
Cerebral Oximetry
Tidsramme: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in cerebral oxymetry measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured evey 10 minutes to obtain the mean of all the values.
Initial, 3 times after spinal block and every 10 minutes during surgery
Mean Arterial Pressure (MAP)
Tidsramme: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in MAP measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values
Initial, 3 times after spinal block and every 10 minutes during surgery
Heart Rate (HR)
Tidsramme: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in HR (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
Initial, 3 times after spinal block and every 10 minutes during surgery
Oxygen arterial saturation (OSat)
Tidsramme: Initial, 3 times after spinal block and every 10 minutes during surgery
Changes in OSat measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
Initial, 3 times after spinal block and every 10 minutes during surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short Portable Mental Status Questionnaire (SPMSQ)
Tidsramme: Once before surgery and at 5th postoperative day
This test measures cognitive impairment before and after surgery
Once before surgery and at 5th postoperative day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Sabadell

Efterforskere

  • Ledende efterforsker: Diana L Fernández Galinski, PhD, Hospital de Sabadell - CSPT

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. februar 2012

Studieafslutning (Forventet)

1. februar 2013

Datoer for studieregistrering

Først indsendt

19. juli 2012

Først indsendt, der opfyldte QC-kriterier

20. juli 2012

Først opslået (Skøn)

23. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011612CSPT

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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