Clinical trial NCT06909942: Association of Sarcopenia With Rocuronium Use in Liver Transplant Recipients
Official title: Association of Sarcopenia With Rocuronium Use in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Sarcopenia in Liver Cirrhosis
Liver Transplantation
Keywords: sarcopenia
psoas muscle index
handgrip dynamometer
liver transplantation
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Idealising Rocuronium Dosing in Sarcopenic Patients With Using Sarcopenia Diagnostic Tests in Preoperative Period
timeFrame: From surgical prosedure to the end of ward observation at 6 months
Secondary outcomes:
measure: 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
timeFrame: From surgical prosedure to the end of treatment at 6 months
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medicine Center Liver Transplantation Institute
state: Battalgazi
Study officials:
affiliation: Inonu University
name: Neslihan Altunkaya Yagci, asisst. prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.