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SarcopeniaNCT06909942

Association of Sarcopenia With Rocuronium Use in Liver Transplant Recipients

A study testing Psoas Muscle Index, Handgrip Dynamometer and SARC-F Score in people with Sarcopenia and Sarcopenia in Liver Cirrhosis, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients will be informed by obtaining consent when they meet the inclusion criteria. Written consent will be obtained when the patient arrives in the operating room. The patient's characteristics (gender, age, liver disease) and the biochemistry, hemogram and coagulation values taken before the surgery will be… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Psoas Muscle Index, Handgrip Dynamometer and SARC-F Score
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2025to 1 Feb 2026
Phase
Interventional
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with American Society of Anesthesiologists (ASA) 3-4,
  • Patients over the age of 18,
  • Liver transplant recipient candidates who have agreed to receive an organ transplant

Who cannot join

  • Patients who are unconscious enough to not be included in the study (patients for whom consent cannot be obtained and the study cannot be explained)
  • Patients under the age of 18
  • Patients aged 65 and over
  • Patients with advanced renal failure
  • Patients with massive ascites in the abdomen
  • Patients with advanced heart failure or high pulmonary artery pressure for whom routine anesthesia induction protocols must be excluded
  • Patients with psychosis or substance abuse Patients with a known adverse reaction to rocuronium
  • Patients who received massive blood and blood product transfusions during surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Turgut Ozal Medicine Center Liver Transplantation Institute

    Malatya, Battalgazi, 44040

Other trials in Turkey (Türkiye)

About this study

Patients will be informed by obtaining consent when they meet the inclusion criteria.

Written consent will be obtained when the patient arrives in the operating room.

Read more

The patient's characteristics (gender, age, liver disease) and the biochemistry, hemogram and coagulation values taken before the surgery will be written on the prepared follow-up form.

After the hand grip strength is recorded in kg with a mechanical thenar muscle dynamometer, the SARC-F test questionnaire consisting of five questions will be administered to the patient and the SARC-F score will be calculated and recorded.

Routine monitoring (ECG, pulse oximetry, non-invasive blood pressure cuff, TOF monitoring, BIS monitoring) will be performed for the liver transplant recipient.

The routine anesthesia induction protocol will be applied to the patient for liver transplant recipients (thiopental (5-7 mg/kg), fentanyl (1-2 mcg/kg) and rocuronium (1mg /kg)), the time after rocuronium will be recorded and the reset time of the TOF device will be determined.The mRSI protocol was applied to all patients, taking into account the risk of aspiration: adequate preoxygenation was followed by short-duration, low-pressure (<20 cmH₂O) mask ventilation. Intubation conditions were assessed using the Modified Helbo-Hansen Raulo Scoring System (5-20 points).

During the case, the times when the TOF value exceeds 30% and the times when diaphragm activity is detected at -3 cmH2O on mechanical ventilation will be recorded, 0.1 mg/kg rocuronium will be added as required for routine anesthesia follow-up. The phase of the transplant operation (Dissection-Anhepatic-Neohepatic) in which the added rocuronium is added will be specified.

The transfusion content and amounts within the case will be recorded on the follow-up form.

The extubation times in hours, the transfer time to the ward, the discharge time from the hospital and the need for reintubation of patients who are routinely transferred to the intensive care unit in an intubated state at the end of the case will be recorded.

Read the detailed description

This prospective observational study will investigate the effect of sarcopenia on rocuronium use in patients scheduled for liver transplantation. The study population will consist of ASA III-IV patients aged 18-65 years who are scheduled to undergo liver transplantation at İnönü University Liver Transplantation Institute. Sarcopenia assessment will be made with a three-stage algorithm: 1. SARC-F Questionnaire: A validated 5-question questionnaire evaluating muscle strength, walking aid, getting up from a chair, climbing stairs, and fall history will be applied. 2. Hand Grip Strength: Will be measured with a mechanical thenar muscle dynamometer and recorded in kg. Values will be compared with reference values determined according to gender. 3. Psoas Muscle Index (PMI): Psoas muscle area will be measured at the level of L3 vertebra on abdominal CT images taken preoperatively for the purpose of operation plan and liver volume evaluation. PMI will be calculated by dividing the total psoas muscle area (cm²) by the square of height (m²). PMI values will be classified according to cut-off values determined by gender. Patients will be informed by obtaining consent when they meet the inclusion criteria. Written consent will be obtained when the patient arrives in the operating room. The patient's characteristics (gender, age, liver disease) and the biochemistry, hemogram and coagulation values taken before the surgery will be written on the prepared follow-up form. After the hand grip strength is recorded in kg with a mechanical thenar muscle dynamometer, the SARC-F test questionnaire consisting of five questions will be applied to the patient and the SARC-F score will be calculated and recorded. Routine monitoring (ECG, pulse oximetry, non-invasive blood pressure cuff, TOF monitoring, BIS monitoring) will be performed for the liver transplant recipient. The patient will be administered the routine anesthesia induction protocol for liver transplant recipients (thiopental (5-7 mg/kg), fentanyl (1-2 mcg/kg) and rocuronium (1 mg/kg)), the time after rocuronium is administered will be recorded and the reset time of the TOF device, which is one of the routine anesthesia monitors, will be determined. After intubation, the intubation score will be written on the follow-up form as a value between 5 and 20. During the case, the times when the TOF value exceeds 30% and the times when diaphragm activity is detected at -3 cmH2O on the mechanical ventilator will be recorded, 0.1 mg/kg rocuronium will be added as required by routine anesthesia follow-up. The phase of the transplant operation (Dissection-Anhepatic-Neohepatic) in which the added rocuronium is added will be specified. The transfusion content and amounts in the case will be written on the follow-up form. The extubation times in hours, transfer times to the ward, discharge times from the hospital and the need for reintubation of patients who are routinely transferred to intensive care in an intubated state at the end of the case will be recorded in the postoperative process. Patients will be extubated using sugammadex, a direct rocuronium antagonist, routinely in the postoperative process.

Being tested
Psoas Muscle Index, Handgrip Dynamometer, SARC-F Score, Train-of-Four(TOF), Bispectral Index(BIS)
Keywords
sarcopenia, psoas muscle index, handgrip dynamometer, liver transplantation
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psoas Muscle IndexDiagnostic test

    The PMI is typically calculated using cross-sectional imaging (CT or MRI) at the level of the third lumbar vertebra (L3).The total psoas area is normalized to patient height: PMI = Total psoas muscle area (cm²) / height² (m²).The PMI is particularly valuable in hospital settings where patients may have difficulty performing functional tests like handgrip strength measurements, offering an objective assessment of muscle status from readily available imaging data.

  • Handgrip DynamometerDevice

    Handgrip strength (HGS) is one of the key diagnostic criteria for sarcopenia according to several international consensus guidelines, including those from the European Working Group on Sarcopenia in Older People (EWGSOP2) and the Asian Working Group for Sarcopenia (AWGS).Men: <27 kg and women: <16 kg values indicates sarcopenia for each patient.Handgrip strength measurement with a dynamometer provides a standardized, reliable, and clinically relevant assessment that helps identify individuals with sarcopenia who may benefit from early intervention strategies.

  • SARC-F ScoreOther

    The SARC-F is a simple screening tool used to identify individuals at risk for sarcopenia, which is the progressive loss of muscle mass and strength typically associated with aging.

    The SARC-F questionnaire consists of 5 components that assess key aspects related to muscle function:

    Strength: Difficulty lifting and carrying 10 pounds Assistance with walking: Difficulty walking across a room Rising from a chair: Difficulty transferring from a chair or bed Climbing stairs: Difficulty climbing a flight of 10 stairs Falls: Frequency of falls in the past year

    Each component is scored from 0-2 points:

    0 = No difficulty

    1. = Some difficulty
    2. = A lot of difficulty or unable to do

    The total score ranges from 0-10, with higher scores indicating higher risk:

    A score of 4 or greater suggests risk of sarcopenia A score of less than 4 suggests low risk

  • Train-of-Four(TOF)Device

    A Train of Four (TOF) device is a specialized neuromuscular monitoring tool used primarily in anesthesiology and critical care to assess the degree of neuromuscular blockade in patients who have received neuromuscular blocking agents (NMBAs).The device delivers four sequential electrical stimuli (hence "train of four") at 0.5-second intervals to a peripheral nerve, typically the ulnar nerve at the wrist. It then measures the resulting muscle contractions, usually of the adductor pollicis muscle (thumb).Modern TOF devices provide a numerical value called the TOF ratio or count, which compares the strength of the fourth twitch to the first twitch.

    Ratio of fourth twitch to first twitch amplitude <0.7: Significant residual blockade 0.7-0.9: Moderate recovery 0.9: Adequate recovery for extubation

  • Bispectral Index(BIS)Device

    A Bispectral Index (BIS) device is a specialized monitoring system used primarily in anesthesiology and critical care to assess a patient's level of consciousness during sedation and general anesthesia.Uses a sensor placed on the patient's forehead to capture electroencephalogram (EEG) signals from the brain.Employs advanced algorithms to analyze the raw EEG data, examining frequency, power, and phase relationships.Processes the EEG information into a dimensionless number (the BIS value) ranging from 0 to 100.

    BIS Scale:

    100-80: Awake, normal consciousness 80-60: Light to moderate sedation 60-40: General anesthesia (surgical level of hypnosis) 40-20: Deep hypnotic state 20-0: Burst suppression to flatline EEG (very deep anesthesia)

Study groups in NCT06909942
Study groupRoleWhat they receive
liver transplantation recipients with sarcopeniaActive comparatorthis arm includes patient with sarcopenia in liver transplantation recipient group.They determined with SARC-F score , hangrip dynamometer value in kilogram and psoas muscle area measurement based on lomber CT scan .
Receives: Diagnostic Test: Psoas Muscle Index; Device: Handgrip Dynamometer; Other: SARC-F Score; Device: Train-of-Four(TOF); Device: Bispectral Index(BIS)
liver transplantation recipients without sarcopeniaPlacebo comparatorthe patients are this arm whom all going liver tranplantation for any reason but they have no sarcopenia in diagnosis algorithm
Receives: Diagnostic Test: Psoas Muscle Index; Device: Handgrip Dynamometer; Other: SARC-F Score; Device: Train-of-Four(TOF); Device: Bispectral Index(BIS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Idealising Rocuronium Dosing in Sarcopenic Patients With Using Sarcopenia Diagnostic Tests in Preoperative Period

    The dose of rocuronium is determined according to the body weight in kilograms of the patients in routine practice. The primary endpoint of our study is to determine whether sarcopenic patients can be identified and induction can be performed with a lower rocuronium dose(mg/kg) than the routine approach.

    Measured: From surgical prosedure to the end of ward observation at 6 months

Secondary outcomes (1)
  1. It is aimed to reduce the length of stay of patients in the service and intensive care unit by adjusting the drug doses that will be used with the detection of sarcopenia

    Postoperative residual neuromuscular blockade increases the risk of postoperative complications. The secondary endpoint of our study was to determine whether the possibility of residual blockade by using lower doses of rocuronium and identifying sarcopenic patients would reduce the duration of extubation time in hour, intensive care, and hospital stay(days).

    Measured: From surgical prosedure to the end of treatment at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Apr 2025
  3. Primary completion6 Oct 2025
  4. Study completion1 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909942
Sponsor's protocol ID
2025/7237
Status last verified
Mar 2026
First submitted
20 Mar 2025
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Takagi S, Sugaya N, Kiuchi N, Iwasa A, Itagaki M, Seki A, Suzuki J, Suzuki T. High-dose rocuronium-induced paralysis of the adductor pollicis muscle facilitates detection of the timing for tracheal intubation in elderly patients: a randomized double-blind study. J Anesth. 2020 Dec;34(6):876-880. doi: 10.1007/s00540-020-02831-6. Epub 2020 Jul 23.

    PubMed 32705417
  • Kuo SZ, Ahmad M, Dunn MA, Montano-Loza AJ, Carey EJ, Lin S, Moghe A, Chen HW, Ebadi M, Lai JC. Sarcopenia Predicts Post-transplant Mortality in Acutely Ill Men Undergoing Urgent Evaluation and Liver Transplantation. Transplantation. 2019 Nov;103(11):2312-2317. doi: 10.1097/TP.0000000000002741.

    PubMed 30985575

Questions about this trial

What is this clinical trial studying?

A study testing Psoas Muscle Index, Handgrip Dynamometer and SARC-F Score in people with Sarcopenia and Sarcopenia in Liver Cirrhosis, run by Inonu University 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 3 inclusion and 8 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 23 Mar 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. Some participants in this study may receive a placebo. 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?

Idealising Rocuronium Dosing in Sarcopenic Patients With Using Sarcopenia Diagnostic Tests in Preoperative Period (time frame: From surgical prosedure to the end of ward observation at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06909942, which also lists 2 linked publications.

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 23 Mar 2026.

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