- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01870453
Differential Effects of Various Anesthetic Agents on Cognitive Function in Patients With Alzheimer's Disease
14 augusti 2018 uppdaterad av: Zhongcong Xie, Massachusetts General Hospital
The objective of the study is to determine the effects of different anesthetic agents on cognitive function in patients with Alzheimer's disease (AD).
The investigators will test the hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients with AD.
Studieöversikt
Status
Indragen
Betingelser
Detaljerad beskrivning
Patients with mild-to-moderate Alzheimer's disease who are scheduled to have elective noncardiac, nonneurologic, nonvascular surgery will be recruited at the Massachusetts General Hospital (MGH).
The study will first be introduced to patients at their preoperative surgical clinic appointment by his/her surgeon.
If patients are interested in participating, they will notify their surgeons, and subsequent recruitment will take place at the MGH Pre-Admission Testing Area (PATA), a clinic for preoperative evaluation and medical optimization.
Patient contact and recruitment, however, will only proceed with permission from (1) the patient him/herself and (2) the patient's surgeon.
Per the Partners Human Research Committees-approved criteria, if patients do not have capacity for clinical-decision making but express a willingness to participate in the study, a surrogate (i.e.
healthcare proxy and/or family member) co-signature will be required on the consent form.
On the day of the subject's surgery, the anesthesia team will be allowed to choose one of four anesthetic options (i.e.
propofol anesthesia, isoflurane anesthesia, sevoflurane anesthesia, or desflurane anesthesia) based on clinical preference and appropriateness.
The research team will be blinded to the anesthetic to which subjects are assigned.
Finally, patients will be followed for one year post-operatively with a battery of cognitive tests to determine differences in cognitive trajectory.
Studietyp
Observationell
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
100 study participants with mild-to-moderate AD who are scheduled to have elective noncardiac, nonneurologic, nonvascular surgery will be recruited at MGH. Surgeons will first introduce the study to patients at their preoperative surgical clinic visit.
If a patient expresses interest in the study, and with permission of the surgeon, the patient will then be contacted by study staff at his/her PATA preoperative evaluation and medical optimization clinic visit.
Recruitment, screening, and enrollment will then occur at the patient's PATA clinic visit.
Beskrivning
Inclusion Criteria:
- Patients diagnosed with Alzheimer's disease (AD) per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
- Patient recruitment permission granted by his/her surgeon
- Requires general anesthesia for elective noncardiac, nonneurologic, nonvascular surgery.
Exclusion Criteria:
- History of neurologic or psychiatric disease (i.e. stroke, psychosis, etc.)
- Non-native English speaker
- Severe visual or auditory disorder
- Sensitivity to sulfites (some propofol formulations at MGH may contain sodium metasulfite).
- Asthma (sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Isoflurane Anesthesia
Recruited subjects that were anesthetized with isoflurane for their surgery.
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Sevoflurane Anesthesia
Recruited subjects that were anesthetized with sevoflurane for their surgery.
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Desflurane Anesthesia
Recruited subjects that were anesthetized with desflurane for their surgery.
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Propofol Anesthesia
Recruited subjects that were anesthetized with propofol for their surgery.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Cognitive Function
Tidsram: 1 week pre-operatively to 1 year post-operatively
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Cognitive function will be assessed using a battery of neuropsychological tests in the domains of attention and executive functions (Trail Making Test, Verbal Fluency Test, Category Switching Test, Symbol Digit Modalities Test), memory (Hopkins Verbal Learning Test-R, Brief Visual Memory Test-R), visuospatial functions (Benton Judgement of Line Orientation Test), and language (Category Fluency Test).
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1 week pre-operatively to 1 year post-operatively
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 oktober 2013
Primärt slutförande (Förväntat)
1 december 2018
Avslutad studie (Förväntat)
1 december 2018
Studieregistreringsdatum
Först inskickad
3 juni 2013
Först inskickad som uppfyllde QC-kriterierna
5 juni 2013
Första postat (Uppskatta)
6 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 augusti 2018
Senast verifierad
1 augusti 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MassGH-001
- HAT-12-237963 (Annat bidrag/finansieringsnummer: Alzheimer's Association)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .