Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID06237751

Preoperative Sildenafil Administration for Hepatectomy to Reduce Bleeding and Improve Surgical Outcomes

Led by First People's Hospital of Chenzhou · Updated on 2024-06-27

16

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Preoperative Sildenafil Administration for Hepatectomy

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing hepatic resection
  • Age between 18 and 85 years
  • Child-Pugh classification A or B
  • ASA physical status II or III
  • Willing to join the trial
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Known allergy to any study medications
  • Hemoglobin level less than 90 g/L
  • Body mass index over 35 kg/m2 or under 18 kg/m2
  • Blood pressure higher than 180 mmHg
  • Kidney impairment with creatinine over 178 µmol/L
  • Severe cardiovascular diseases such as active coronary artery disease, severe valve stenosis, hypertrophic obstructive cardiomyopathy, or stroke within the last six months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Post-operative Follow-up

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

Trial Site Locations

Total: 1 location

1

Zhiming Zhang

Chenzhou, Hunan, China, 423000

Actively Recruiting

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Research Team

Q

Qisheng Z Chen

P

pan wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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