Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients
13. maj 2026 opdateret af: Betul Kozanhan, Konya Meram State Hospital
This prospective observational study aims to evaluate whether sarcopenia and frailty affect the pharmacodynamic profile of rocuronium in geriatric patients undergoing elective surgery under general anesthesia.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Betül kozanhan, M.D.
- Telefonnummer: 05055044808
- E-mail: betulkozanhan@gmail.com
Studiesteder
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Konya, Tyrkiet (Türkiye), 42005
- Rekruttering
- Betul Kozanhan
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Kontakt:
- Betul Kozanhan
- Telefonnummer: (0332) 310 50 00
- E-mail: betulkozanhan@gmail.com
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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
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population will consist of geriatric patients aged 65 years or older who are scheduled for elective surgery under general anesthesia with endotracheal intubation and rocuronium-induced neuromuscular blockade.
Before surgery, patients will be evaluated for frailty and sarcopenia using predefined clinical and ultrasonographic criteria.
According to these assessments, patients will be classified into four cohorts: frailty only, sarcopenia only, both frailty and sarcopenia, and neither frailty nor sarcopenia.
Beskrivelse
Inclusion Criteria:
- Scheduled to undergo elective surgery under general anesthesia requiring endotracheal intubation
- Planned use of rocuronium for neuromuscular blockade
- Quantitative neuromuscular monitoring planned during anesthesia
- American Society of Anesthesiologists physical status I-III
- Ability to provide written informed consent
- Completion of preoperative frailty and sarcopenia assessment
Exclusion Criteria:
- Emergency surgery
- Known neuromuscular disease
- History of allergy or contraindication to rocuronium, sugammadex
- Severe hepatic insufficiency
- Severe renal insufficiency
- Use of drugs known to significantly affect neuromuscular transmission
- Preoperative mechanical ventilation or intensive care unit admission
- Inability to perform a frailty or sarcopenia assessment
- Patients in whom quantitative neuromuscular monitoring cannot be properly performed
- Refusal to participate in the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Group/Cohort 1-Frailty
Presence of frailty based on the Fried frailty phenotype.
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Group/Cohort 2-Sarcopenia
Presence of sarcopenia based on preoperative clinical and ultrasonographic assessment.
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Group/Cohort 3 - Frail and Sarcopenic Group
Geriatric patients who meet the criteria for both frailty and sarcopenia.
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Group/Cohort 4 - Control Group
Geriatric patients who meet neither frailty nor sarcopenia criteria.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rocuronium onset time
Tidsramme: Perioperative/Periprocedural - during anesthesia induction
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Time from intravenous administration of rocuronium to disappearance of all train-of-four responses, defined as train-of-four count 0, measured using quantitative neuromuscular monitoring
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Perioperative/Periprocedural - during anesthesia induction
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time from train-of-four count 0 to train-of-four count 2
Tidsramme: From achievement of train-of-four count 0 after the initial rocuronium dose until recovery of train-of-four count 2 during surgery
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Time elapsed from achievement of train-of-four count 0 after the initial rocuronium dose to recovery of train-of-four count 2, recorded in minutes and measured using quantitative neuromuscular monitoring.
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From achievement of train-of-four count 0 after the initial rocuronium dose until recovery of train-of-four count 2 during surgery
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Time to train-of-four ratio 0.9 after sugammadex administration
Tidsramme: From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery
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Time from sugammadex administration to recovery of train-of-four ratio to 0.9, measured using quantitative neuromuscular monitoring.
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From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery
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Total rocuronium dose
Tidsramme: From anesthesia induction until the end of surgery
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Total dose of rocuronium administered during anesthesia
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From anesthesia induction until the end of surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Betül Kozanhan, M.D., SBÜ Konya EAH
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 (Faktiske)
13. maj 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
5. august 2026
Datoer for studieregistrering
Først indsendt
29. april 2026
Først indsendt, der opfyldte QC-kriterier
6. maj 2026
Først opslået (Faktiske)
12. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ROC-SARC-FRAIL-2025
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 .