Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients

NCT07580144 | Recruiting

• 1 other identifier: ROC-SARC-FRAIL-2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Frailty; Neuromuscular Blockade; Rocuronium; Pharmacodynamics

Outcome Measures

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

  Perioperative/Periprocedural - during anesthesia induction

Secondary Outcomes (3)

• Time from train-of-four count 0 to train-of-four count 2

  From achievement of train-of-four count 0 after the initial rocuronium dose until recovery of train-of-four count 2 during surgery

• Time to train-of-four ratio 0.9 after sugammadex administration

  From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery

• Total rocuronium dose

  From anesthesia induction until the end of surgery

Study Arms (4)

Group/Cohort 1-Frailty

Presence of frailty based on the Fried frailty phenotype.

Group/Cohort 2-Sarcopenia

Presence of sarcopenia based on preoperative clinical and ultrasonographic assessment.

Group/Cohort 3 - Frail and Sarcopenic Group

Geriatric patients who meet the criteria for both frailty and sarcopenia.

Group/Cohort 4 - Control Group

Geriatric patients who meet neither frailty nor sarcopenia criteria.

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Betül Kozanhan, M.D.

  SBÜ Konya EAH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül kozanhan, M.D.

CONTACT

05055044808; betulkozanhan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TU (1)