Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-80
SponsorKonya Meram State Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Emergency surgery
Known neuromuscular disease
History of allergy or contraindication to rocuronium, sugammadex
Severe hepatic insufficiency
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 4 trial groupsGroup A: Group/Cohort 1-Frailty
Group B: Group/Cohort 2-Sarcopenia
Group C: Group/Cohort 3 - Frail and Sarcopenic Group
Group D: Group/Cohort 4 - Control Group
Trial outcomes
Primary outcomes
1
Rocuronium onset time
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
Time frame
Perioperative/Periprocedural - during anesthesia inductionSecondary outcomes
1
Time from train-of-four count 0 to train-of-four count 2
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.
Time frame
From achievement of train-of-four count 0 after the initial rocuronium dose until recovery of train-of-four count 2 during surgery2
Time to train-of-four ratio 0.9 after sugammadex administration
Time from sugammadex administration to recovery of train-of-four ratio to 0.9, measured using quantitative neuromuscular monitoring.
Time frame
From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery3
Total rocuronium dose
Total dose of rocuronium administered during anesthesia
Time frame
From anesthesia induction until the end of surgerySponsors and contacts
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Source ClinicalTrials.gov