Preoperative Sildenafil Administration for Hepatectomy

Hepatectomy Clinical Trial

Official title: Preoperative Sildenafil Administration for Hepatectomy

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1.2 Content of the study

1. Feasibility and effectiveness of sildenafil citrate applied in LH to control low central venous pressure By letting the patients take sildenafil citrate 50mg orally before operation. ① Record intraoperative blood loss, intraoperative low central venous pressure and surgeon's field grading.

• Recorded intraoperative hemodynamic indexes (HR ; MAP; SVV) changes: at patient admission (T0), after induction (T1), 15 min after the start of surgery (T2), start of hepatectomy (T3), after hepatectomy (T4), and at the end of surgery (T5).

(iii) Record intraoperative conditions: operation time, hepatic portal block time, intraoperative blood transfusion rate, intraoperative urine volume, intraoperative fluid volume, and intraoperative vasoactive drugs

• Record metabolic indexes: T1, T4, T5 for blood gas analysis and record PH, lactate value, hemoglobin level (Hb).

(2) The safety of sildenafil citrate applied in LH to control low central venous pressure, and to clarify that the use of sildenafil does not lead to other complications

① By collecting preoperative and postoperative 1, 3, 7 days liver and kidney functions: measuring serum bilirubin, serum albumin, prolongation time of plasminogen, alanine aminotransferase, glutamine aminotransferase, urea nitrogen, creatinine.

②Patient hospitalization time

③Total cost of hospitalization of the patient

• Drainage tube placement time

• Postoperative pain score ⑥ Postoperative complications: nausea, vomiting, no anal evacuation within 5 days after surgery, etc.; abdominal ultrasonography revealed that abdominal fluid was more than 200 ml, which required laparotomy for diagnosis of peritoneal hemoperitoneum; the diagnostic criteria for postoperative hepatic failure included persistent hyperbilirubinemia (>50 mmol/L), ascites, coagulation dysfunction (INR>1.7), and hepatic encephalopathy; ;

Related Conditions & MeSH terms

• Central Venous Pressure
• Hemodynamics Instability
• Hepatectomy
• Sildenafil

• NCT number: NCT06237751
• Study type: Interventional
• Source: First People's Hospital of Chenzhou
• Contact: Qisheng Z Chen
• Phone: +8618711451175
• Email: cqs19990715@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2024
• Completion date: August 1, 2024