Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237751
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-12-03
Brief Title:
Preoperative Sildenafil Administration for Hepatectomy
Sponsor:
First Peoples Hospital of Chenzhou
Organization:
First Peoples Hospital of Chenzhou
Study Overview
Official Title:
Preoperative Sildenafil Administration for Hepatectomy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
1 FeasibilityEffectiveness evaluation indicators
Primary outcomes
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 1054 average density of blood in gml
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 patients 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
Secondary outcomes
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
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
2 Safety evaluation indicators
Blood gas analysis Measure Hb PH and Lac at T1 T3 T4 and T5 to understand the patients internal environment status
Coagulation functionUnderstand the changes in the coagulation function of the patient during the operation by measuring the TEG of the patient at T2 and T5 and measure the APTT and PT values at D1 D3 and D5 to understand whether there is an impact on the patients postoperative coagulation function after taking Sildenafil
Intraoperative urine output By recording the intraoperative urine output value of the patient at T6
Adverse events in the recovery roomIt is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room
Biochemical markers Liver and kidney functions It is evaluated by measuring the levels of TBil Alb AST ALT Cr BUN of the patients on days -D1 D1 D3 and D5
Complete blood count At -D1 D1 D3 and D5 it is evaluated by measuring the patients postoperative Hb Plt and Hct
Cardiac function By comparing the levels of BNP CK-MB and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patients cardiac function
Postoperative hospital stay and drainage indwelling time Record the patients hospital stay and drainage tube placement time to assess the patients recovery speed
Postoperative complications Whether to enter the ICU after surgery liver failure bleeding bile leakage ascites pleural effusion and incision site infection
- D1 The day before surgery - T0 half an hour before surgery T0 entering the operating room T1 post induction T2 5 minutes after 30 head-up and foot-down position T3 30 minutes after the start of liver resection T4 60 minutes after the start of liver resection T5 after liver resection T6 at the end of the operation D1 Postoperative day 1 D3 Postoperative day 3 D5 Postoperative day 5
Primary outcomes
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 1054 average density of blood in gml
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 patients 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
Secondary outcomes
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
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
2 Safety evaluation indicators
Blood gas analysis Measure Hb PH and Lac at T1 T3 T4 and T5 to understand the patients internal environment status
Coagulation functionUnderstand the changes in the coagulation function of the patient during the operation by measuring the TEG of the patient at T2 and T5 and measure the APTT and PT values at D1 D3 and D5 to understand whether there is an impact on the patients postoperative coagulation function after taking Sildenafil
Intraoperative urine output By recording the intraoperative urine output value of the patient at T6
Adverse events in the recovery roomIt is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room
Biochemical markers Liver and kidney functions It is evaluated by measuring the levels of TBil Alb AST ALT Cr BUN of the patients on days -D1 D1 D3 and D5
Complete blood count At -D1 D1 D3 and D5 it is evaluated by measuring the patients postoperative Hb Plt and Hct
Cardiac function By comparing the levels of BNP CK-MB and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patients cardiac function
Postoperative hospital stay and drainage indwelling time Record the patients hospital stay and drainage tube placement time to assess the patients recovery speed
Postoperative complications Whether to enter the ICU after surgery liver failure bleeding bile leakage ascites pleural effusion and incision site infection
- D1 The day before surgery - T0 half an hour before surgery T0 entering the operating room T1 post induction T2 5 minutes after 30 head-up and foot-down position T3 30 minutes after the start of liver resection T4 60 minutes after the start of liver resection T5 after liver resection T6 at the end of the operation D1 Postoperative day 1 D3 Postoperative day 3 D5 Postoperative day 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None