Association of Sarcopenia With Rocuronium Use in Liver Transplant Recipients

NCT06909942 | Completed

• 1 other identifier: 2025/7237
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sarcopenia; Sarcopenia in Liver Cirrhosis; Liver Transplantation

Keywords

sarcopenia; psoas muscle index; handgrip dynamometer; liver transplantation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (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

  From surgical prosedure to the end of treatment at 6 months

Study Arms (2)

liver transplantation recipients with sarcopenia

ACTIVE COMPARATOR

this 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 .

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 sarcopenia

PLACEBO COMPARATOR

the patients are this arm whom all going liver tranplantation for any reason but they have no sarcopenia in diagnosis algorithm

Diagnostic Test: Psoas Muscle Index; Device: Handgrip Dynamometer; Other: SARC-F Score; Device: Train-of-Four(TOF); Device: Bispectral Index(BIS)

Interventions

Psoas Muscle Index DIAGNOSTIC_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.

liver transplantation recipients with sarcopenia; liver transplantation recipients without sarcopenia

Handgrip Dynamometer DEVICE

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.

liver transplantation recipients with sarcopenia; liver transplantation recipients without sarcopenia

SARC-F Score OTHER

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

liver transplantation recipients with sarcopenia; liver transplantation recipients without sarcopenia

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

liver transplantation recipients with sarcopenia; liver transplantation recipients without sarcopenia

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)

liver transplantation recipients with sarcopenia; liver transplantation recipients without sarcopenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Turgut Ozal Medicine Center Liver Transplantation Institute

Malatya, Battalgazi, 44040, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32705417 RESULT

• 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.

  PMID: 30985575 RESULT

MeSH Terms

Conditions

Sarcopenia

Interventions

Neuromuscular Monitoring; Consciousness Monitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Surgical Equipment; Equipment and Supplies

Study Officials

• Neslihan Altunkaya Yagci, asisst. prof.

  Inonu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant anesthesiologist

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: October 6, 2025
• Study Completion: February 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)