Perioperative sildenafil citrate administration in hepatectomy: a study protocol of randomized controlled trial.
Qisheng Chen, Shixuan Peng, Yingying Zhou...
https://pubmed.ncbi.nlm.nih.gov/40450350Actively Recruiting
Led by First People's Hospital of Chenzhou · Updated on 2024-06-27
16
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are studying the use of preoperative oral Sildenafil Citrate in patients undergoing liver surgery, called hepatectomy. The goal is to see if Sildenafil, combined with the Control Low Central Venous Pressure (CLCVP) technique, can reduce bleeding during surgery and improve surgical outcomes. This study also aims to evaluate the safety and feasibility of this approach, as bleeding is a common complication during liver surgery and current methods mainly focus on reducing blood volume return without addressing other factors like heart and lung function. Participants will receive 100 mg of Sildenafil orally half an hour before their open or laparoscopic hepatectomy surgery. The study will assess how this treatment affects intraoperative blood loss and the quality of the surgical field. If the surgical field score is low, the CLCVP technique will be used to improve conditions, and the surgeon will reassess its effectiveness. The study also monitors the use of nitroglycerine, heart and blood pressure parameters at multiple points during surgery, and other vital signs to understand the treatment's effects on hemodynamic stability. During the study, participants will undergo various assessments including blood gas analysis, coagulation tests, urine output measurement, and monitoring for adverse events after surgery. Researchers will also track liver and kidney function, blood counts, cardiac markers, hospital stay length, drainage time, and postoperative complications such as liver failure or infection. These evaluations will take place before surgery, during surgery, and up to five days after surgery to ensure comprehensive safety and outcome monitoring.
CONDITIONS
Preoperative Sildenafil Administration for Hepatectomy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants take Sildenafil 100 mg orally half an hour before undergoing hepatic resection surgery to reduce bleeding and improve surgical outcomes.
1 preoperative visit and surgery day procedures
Duration - 5 days post-surgery
Participants are monitored for recovery including blood tests, liver and kidney function, cardiac function, and postoperative complications up to 5 days after surgery.
Visits on postoperative days 1, 3, and 5
Total: 1 location
1
Zhiming Zhang
Chenzhou, Hunan, China, 423000
Actively Recruiting
Q
Qisheng Z Chen
P
pan wang
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Qisheng Chen, Shixuan Peng, Yingying Zhou...
https://pubmed.ncbi.nlm.nih.gov/40450350