Clinical Trials Logo

Clinical Trial Summary

The use of muscle relaxants is an indispensable in the general anesthesia but is prone to accidents, which are often related to residual muscle relaxant. Therefore, how to timely and effectively eliminate the residual effect of muscle relaxants after surgery has become an urgent clinical problem. Rocuronium is a non-depolarizing muscle relaxant that is primarily metabolized by the liver. Patients with liver dysfunction can affect the metabolic process of rocuronium, thereby delaying the recovery of muscle relaxation. Sugammadex (SUG) is a novel specific antagonist of aminosteroid muscle relaxants, which can effectively antagonize muscle relaxants at different depths. However, whether liver dysfunction affects the antagonistic effect of SUG against rocuronium has not been reported yet. Therefore, the investigators hypothesize that with the increase of patients' liver Child-Pugh grade, the recovery time of rocuronium antagonized by the same dose of SUG after surgery will be prolonged, and the incidence of muscle relaxation residual will be increased in the short term.

Clinical Trial Description

Main instruments: Drager Fabius anesthesia machine, interlive vue MX600 monitor, Train-Of-Four-Watch muscle relaxation monitor, Philips IU22 Color Doppler Ultrasound Diagnostic Instrument. Diaphragm ultrasound scan: Prior to anesthesia induction, patients will lie on the bed in a semi-recumbent (45°) position. One operator skilled in ultrasonography will identify and locate diaphragm using the hyperechoic pleural and peritoneal layers with an Philips IU22 Color Doppler Ultrasound Diagnostic Instrument. Anesthesia method: After the patient entered the operating room, venous access will be opened in the forearm, and routine monitoring of non-invasive BP, ECG, oxygen saturation(SpO₂) and bispectral index(BIS) will be performed. During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. By the time T1=0, endotracheal intubation will be given, and the respiratory parameters will need to be adjusted to volume control ventilation (VT 8-10 ml/kg, respiratory rate(RR) 12-18 times/min, and PETCO2 35-45 mmHg). During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol target-controlled infusion(TCI) will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2. Muscle relaxation monitoring: TOF-Watch SX muscle relaxation monitor is going to be adopted in our study. The investigators will standardize the electrode position of the muscle relaxation monitor. The distal electrode will be placed at the intersection of the radial edge of the ulnar flexor carpi and the proximal edge of the wrist curve, while the proximal electrode will be placed 3-6 cm away from the distal electrode. Two electrodes will put on either side of the predicted location of the ulnar nerve, which will be able to minimize the impact caused by misjudgment of the location of the nerve. Measurement of diaphragmatic thickness: When B-mode ultrasound will be used to measure the thickness of the diaphragm, a 5-12MHz linear array ultrasound probe will be put in the left midaxillary line between the 8-10 costale, where is called the diaphragmatic zone of apposition (ZAP). In the breathing exercise, the diaphragm is relatively fixed at ZAP, and the breathing action has little influence on the movement of the diaphragm at ZAP, the diaphragm only shows systolic and diastolic changes. Therefore, the measurement of the diaphragm thickness at ZAP can truly reflect the overall thickness change of the diaphragm during the respiratory cycle. Each value will be measured three times in three consecutive breathing cycles, and the average of the nine measurements will be taken. The values of diaphragmatic thickness at the end of inspirations (DTEI) and diaphragmatic thickness at the end of expirations (DTEE) will be recorded respectively, then the change rate of diaphragmatic thickness fraction (DTF) = (DTEI - DTEE) / DTEE × 100% will be calculated. In addition, the recover rate of DTF = (pre-anesthetic DTEI - postoperative DTEI) / pre-anesthetic DTEI × 100% also will be figured out. Ultrasound measurements should be performed by two physicians with ultrasound experience. Results will be kept confidential to the investigator, who will analyze the ultrasound data when the research is over. The infusion of anesthetic drugs should be stopped at the end of surgery, and the patients will be transferred into the Post-Anesthesia Care Unit (PACU) with endotracheal catheters and continued monitoring. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg), respectively. The researchers will record the recovery conditions of diaphragmatic function monitored by bedside ultrasound at the immediate time,10min, 30min and 2h after extubation. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05028088
Study type Interventional
Source Wuhan Union Hospital, China
Contact Yun Lin, MD, PhD.
Phone +86 02785351606
Email [email protected]
Status Recruiting
Phase Phase 4
Start date July 1, 2021
Completion date December 2022

See also
  Status Clinical Trial Phase
Completed NCT02754219 - Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction Phase 1
Terminated NCT01079104 - Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units N/A
Recruiting NCT00553553 - Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery N/A
Completed NCT03641872 - A Validation Cohort for ACLF Diagnosis and Prognosis
Completed NCT03371537 - Study of Hemodynamic Conditions Measured During Hepatectomy
Recruiting NCT02473601 - Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis Phase 2
Completed NCT01000337 - Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol N/A
Completed NCT03155984 - Optimizing HBV Management During Anti-CD20 Antibodies
Completed NCT03515980 - An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function Phase 1
Completed NCT01338714 - The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function Phase 3
Completed NCT02005744 - A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function Phase 1
Completed NCT01367522 - Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function Phase 1
Recruiting NCT03805139 - Role of Ajwa Derived Polyphenols in Dyslipidaemias N/A
Completed NCT02949505 - Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation N/A
Completed NCT02991339 - The Effects of Dexamethasone Administration on Jaundice Following Liver Resection Phase 2/Phase 3
Completed NCT02992639 - Weight Loss Effect on Circulating Liver Enzymes N/A
Recruiting NCT03519074 - Cisplatin Combined With Oral TS-1 in Patients With Advanced Solid Tumors With Different Degrees of Liver Dysfunction Phase 2
Recruiting NCT02882113 - Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion Phase 4
Completed NCT01876108 - The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT04004481 - Metabolites of Tramadol in the Postoperative Surgical Patients