Preoperative Sildenafil Administration for Hepatectomy

NCT06237751 | Recruiting DMC

• 1 other identifier: 2023139
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Venous Pressure; Hepatectomy; Hemodynamics Instability; Sildenafil

Keywords

Sildenafil Citrate; Hepatectomy; Laparoscopy; Low central venous pressure; Study protocol

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss

  To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).

  At the end of the operation

• The classification of the surgical field

  At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process.(At 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))

  At the end of the operation

Secondary Outcomes (12)

• Cumulative consumption of nitroglycerine

  At the end of the operation

• Hemodynamic parameters

  At the end of the operation

• Blood gas analysis

  At the end of the operation

• Intraoperative urine output

  At the end of the operation(T6)

• Adverse events in the recovery room

  After the end of surgery, Patient in recovery room.

Study Arms (1)

calcium tablet

OTHER

calcium tablet

Drug: Sildenafil 100 MG

Interventions

Sildenafil 100 MG DRUG

Sildenafil 100mg orally half an hour before surgery

Also known as: nitroglycerine

calcium tablet

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Chenzhou: lead

Study Sites (1)

Zhiming Zhang

Chenzhou, Hunan, 423000, China

RECRUITING

Related Publications (1)

• Chen Q, Peng S, Zhou Y, Li S, Xu F, Yu Y, Wang P, Peng X, Zhao C, Xie A, Zhang Z. Perioperative sildenafil citrate administration in hepatectomy: a study protocol of randomized controlled trial. Trials. 2025 Jun 1;26(1):183. doi: 10.1186/s13063-025-08870-2.

  PMID: 40450350 DERIVED

MeSH Terms

Interventions

Sildenafil Citrate; Nitroglycerin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitro Compounds

Study Officials

• Zhi-ming Z Zhang

  Chenzhou NO. 1 people's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qisheng Z Chen

CONTACT

+8618711451175; cqs19990715@163.com

pan wang

CONTACT

+8618075506668; Showmeyoumoney@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)