Preoperative Sildenafil Administration for Hepatectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFirst People's Hospital of Chenzhou
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Patients undergoing hepatic resection
age from 18-85 years
Child-Pugh ≤B
ASA II-III
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sildenafil 100 MG
DrugSildenafil 100mg orally half an hour before surgery
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: calcium tabletOther 1 intervention
Trial outcomes
Primary outcomes
1
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)).
Time frame
At the end of the operation2
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))
Time frame
At the end of the operationSecondary outcomes
1
Cumulative consumption of nitroglycerine
Based on the criterion of CLCVP, record whether the patient needs to use nitroglycerine during the operation and the dose used.
Time frame
At the end of the operation2
Hemodynamic parameters
Collect data such as SBP, DBP, MAP, CVP, CO, SV, SVV, SVR, HR, SpO2 at the time when the patient enters the operating room (T0), after induction (T1), 15 minutes after adjusting the body position (T2), 30 minutes after the start of liver resection (T3), 60 minutes after the start of liver resection (T4), after liver resection (T5), and at the end of the operation (T6) to assess the influence of sildenafil on the intraoperative hemodynamic stability.
Time frame
At the end of the operation3
Blood gas analysis
Measure Hb, PH, and Lac at T1, T3, T4, and T5 to understand the patient's internal environment status.(At post induction(T1), 5 minutes after 30° head-up and foot-down position(T2), 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))
Time frame
At the end of the operation4
Intraoperative urine output
By recording the intraoperative urine output value of the patient at T6.
Time frame
At the end of the operation(T6)Sponsors and contacts
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Source ClinicalTrials.gov