Association of Sarcopenia With Rocuronium Use in Liver Transplant Recipients

Not Applicable

Recruiting

• Conditions: Sarcopenia; Sarcopenia in Liver Cirrhosis; Liver Transplantation

• Registration Number: NCT06909942
• Lead Sponsor: Inonu University

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 (0.6 mg /kg)), the time after rocuronium will be recorded and the reset time of the TOF device will be determined.

After intubation, the intubation score will be recorded 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 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.

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 II-III 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 (0.6 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Study Start: 2025-04-01
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-10-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients with American Society of Anesthesiologists (ASA) 2-3,
• Patients over the age of 18,
• Liver transplant recipient candidates who have agreed to receive an organ transplant

Exclusion Criteria

• 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 with indications for rapid sequence intubation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Idealising Rocuronium Dosing in Sarcopenic Patients With Using Sarcopenia Diagnostic Tests in Preoperative Period	From surgical prosedure to the end of ward observation at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Turgut Ozal Medicine Center Liver Transplantation Institute; 🇹🇷 Malatya, Battalgazi, Turkey