Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients

May 13, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rocuronium onset time
Time Frame: Perioperative/Periprocedural - during anesthesia induction
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from train-of-four count 0 to train-of-four count 2
Time Frame: From achievement of train-of-four count 0 after the initial rocuronium dose until recovery of train-of-four count 2 during surgery
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.
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
Time Frame: From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery
Time from sugammadex administration to recovery of train-of-four ratio to 0.9, measured using quantitative neuromuscular monitoring.
From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery
Total rocuronium dose
Time Frame: From anesthesia induction until the end of surgery
Total dose of rocuronium administered during anesthesia
From anesthesia induction until the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Investigators

  • Principal Investigator: Betül Kozanhan, M.D., SBÜ Konya EAH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 5, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROC-SARC-FRAIL-2025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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