SarcopeniaNCT07580144
Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients
An observational study of Sarcopenia and Frailty, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sarcopenia, Frailty, Neuromuscular Blockade
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2026to 27 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative/Periprocedural - during anesthesia induction
Secondary outcomes (3)
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.
Measured: 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 from sugammadex administration to recovery of train-of-four ratio to 0.9, measured using quantitative neuromuscular monitoring.
Measured: From sugammadex administration until recovery of train-of-four ratio to 0.9 at the end of surgery
Total rocuronium dose
Total dose of rocuronium administered during anesthesia
Measured: From anesthesia induction until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start13 May 2026
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
- Investigators
- Betül Kozanhan, M.D., Principal investigator, SBÜ Konya EAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580144
- Sponsor's protocol ID
- ROC-SARC-FRAIL-2025
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarcopenia and Frailty on Rocuronium Pharmacodynamics in Geriatric Patients
- ClinicalTrials.gov ID
- NCT07580144
- Acronym / sponsor ID
- ROC-SARC-FRAIL-2025
- Conditions
- Sarcopenia, Frailty, Neuromuscular Blockade, Rocuronium, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Emergency surgery
- Known neuromuscular disease
- History of allergy or contraindication to rocuronium, sugammadex
- Severe hepatic insufficiency
- Severe renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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 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
Total rocuronium dose
Time frame: From anesthesia induction until the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Kozanhan, M.D. principal investigator
SBÜ Konya EAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Frailty, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rocuronium onset time (time frame: Perioperative/Periprocedural - during anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.