RecruitingNot ApplicableNCT06237751

Preoperative Sildenafil Administration for Hepatectomy


Sponsor

First People's Hospital of Chenzhou

Enrollment

16 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Hepatectomy is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. The 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 the 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 action inhibits phosphodiesterase-5 (PDE-5) and increases 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 liver resection related to CLCVP. This study aims to investigate the influence of preoperative oral administration of Sildenafil Citrate combined with IPM on IBL and surgical results during open or laparoscopic hepatectomy, as well as its safety and feasibility. It is expected to provide an innovative management optimization plan for reducing the bleeding in hepatectomy and to provide empirical support for the potential value of Sildenafil Citrate or Sildenafil-like drugs in improving the safety and quality of perioperative hepatectomy patients.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • Patients undergoing hepatic resection
  • age from 18-85 years
  • Child-Pugh ≤B
  • ASA II-III
  • willing to join the trial.

Exclusion Criteria7

  • 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.

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Interventions

DRUGSildenafil 100 MG

Sildenafil 100mg orally half an hour before surgery


Locations(1)

Zhiming Zhang

Chenzhou, Hunan, China

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NCT06237751


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