Preoperative Sildenafil Administration for Hepatectomy

Hepatectomy Clinical Trial

Official title:

Preoperative Sildenafil Administration for Hepatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237751
• Other study ID #: 2023139
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: First People's Hospital of Chenzhou
• Contact: Qisheng Z Chen
• Phone: +8618711451175
• Email: cqs19990715[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Pressure
• Hemodynamics Instability
• Hepatectomy
• Sildenafil

Intervention

Drug:
• Sildenafil 25 MG
Sildenafil 25mg orally half an hour before surgery

Locations

Country	Name	City	State
China	Zhiming Zhang	Chenzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Chenzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemorrhage	The blood volume of the suction bottle and the weight of the gauze blood pads were counted by counting the blood volume of the suction bottle and the weight of the gauze blood pads 2minutes before the end of the procedure.- Expected volume of blood absorbed by the gauze block (ml) = (weight of gauze block after blood absorption g minus weight of gauze block before blood absorption g)/1.054 (average density of blood g/ml) Weight of gauze blood cushion Expected volume of blood absorbed by the gauze block ml weight of the gauze block after suction g - weight of the gauze block before suction g1054 average density of blood gml	2minutes before the end of the operation
Primary	CVP	Measurement of CVP pressure by placing a central venous catheter	2minutes after patient admission, 2minutes after induction of anesthesia, 15minutes after start of surgery, 2minutes after start of hepatectomy, 2minutes after hepatectomy, 2minutes before end of surgery
Primary	Operative field grading	Using a pilot study performed to assess the effect of sildenafil on the surgical field condition using four-point scale :1Grade(The inferior vena cava and hepatic vein are very flaccid and the liver section bleeds very little, making it easy to perform the procedure.)2Grade(The inferior vena cava and hepatic vein are relaxed and the hepatic section bleeds less, making it easier to perform the procedure.)3Grade(Tension in the inferior vena cava and hepatic vein, more blood leakage from the liver section, more difficult to perform surgery)4Grade(The tension in the inferior vena cava and hepatic vein is very high, and the liver section bleeds a lot, which makes it very difficult to perform surgery)	2minutes before the end of surgery
Secondary	liver function	By recording the results of liver function before and after operation in the control group and the experimental group, the liver-related indexes include alanine aminotransferase (ALT), aspartate transferase (AST), ALT /AST and lactate dehydrogenase (LDH). The data of ALT, AST, ALT /AST and LDH were recorded and compared between groups, and whether there were differences between the two groups was compared (P<0.05).	1 day before surgery, 1 day after surgery, 3rd day after surgery
Secondary	kidney function	By comparing the results of blood urea nitrogen (BUN) and creatine (Cr) before and after operation in the control group and the experimental group. If the creatine (Cr) value of postoperative renal function test is greater than 178 µmol/L, it suggests that the patient may have renal function damage. Record the data of BUN and creatine on the first day before operation, the first day after operation and the third day after operation, and compare whether there are differences between the two groups (if P<0.05, it means that there are differences between the experimental group and the control group).	1 day before surgery, 1 day after surgery, 3rd day after surgery
Secondary	Drainage tube placement time	Ask the patient and the physician in charge	Postoperative day three
Secondary	Postoperative pain score	The degree of pain during follow-up was predicted by VAS pain score, with 0 score: painless; Below 3 points: mild pain, tolerable; 4 points and 6 points: the patient has pain and affects sleep, which is tolerable; 7 -10: The patient has gradually intense pain, which is unbearable and affects appetite and sleep.	Postoperative day three
Secondary	Total cost of hospitalization	Ask the patient and the physician in charge	Postoperative day three
Secondary	Patient length of stay	Ask the patient and the physician in charge	Postoperative day three