Preoperative Sildenafil Administration for Hepatectomy

2023139

Laparoscopic Hepatectomy (LH) is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. Control Low Central Venous Pressure (CLCVP) technique is currently one of the most important techniques to control intraoperative bleeding. It mainly consists of fluid restriction, position adjustment and use of vasodilators. However, these measures focus on decreasing CVP by reducing the volume of return blood, and less attention is paid to factors such as pulmonary vascular resistance and cardiac function. Sildenafil, known as Viagra, is currently used to treat erectile dysfunction and pulmonary hypertension in men. Its mechanism of action is to inhibit phosphodiesterase-5 (PDE-5) and increase cGMP levels leading to smooth muscle relaxation and vasodilation. Its pharmacological properties provide potential value for the treatment of many diseases. However, few studies have been conducted both domestically and internationally on the use of sildenafil citrate in LH related to CLCVP. The aim of this study is to investigate the following aspects: 1) the feasibility and effectiveness of sildenafil citrate applied to control low central venous pressure in LH, such as intraoperative bleeding, the impact of CVP, and the surgeon's operative field grading to assess the value of its clinical application; 2) the impact of sildenafil citrate applied to the function of the liver and important organs of the kidneys of the patients after LH surgery as well as the incidence of postoperative complications, and to assess the clinical application of its Safety.

2024-01-31

2024-06-01

2024-08-01

Not yet recruiting

16

Inclusion Criteria: * Patients undergoing hepatic resection * age from 18-85 years * Child-Pugh ≤B * ASA II-III * willing to join the trial. Exclusion Criteria: * Pregnancy or Lactation * Known Allergy to any Medications used in the Study * Hemoglobin (Hb) \< 90 g/L * Body Mass Index (BMI) \> 35 kg/m2 or \< 18 kg/m2 * Hypertension \> 180 mmHg * Renal Impairment (Creatinine, Cr 178 µmol/L) * Severe Cardiovascular Diseases including Active Coronary Artery Disease, Severe Valve Stenosis and Hypertrophic Obstructive Cardiomyopathy, History of Stroke Within Six Months.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The investigators planned a study to evaluate the feasibility and efficacy of sildenafil citrate by comparing 2 groups of patients, the first without the drug and the second with 25 mg of sildenafil citrate.1) Feasibility and efficacy were assessed by comparing the amount of intraoperative bleeding, the effect of CVP, and the surgeon's operative field grading.2) Liver and renal function indexes, length of hospitalization, hospitalization costs, and postoperative complications were assessed by comparing patients' preoperative, 1d postoperative, 3d postoperative, and 7d postoperative occurrence, to assess the safety of its clinical application.", 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2024-02-01