RecruitingNot ApplicableNCT06468852

GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial

Sponsor

Beijing Tongren Hospital

Enrollment

340 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Complications

Summary

The goal of this clinical trial is to evaluate whether goal-directed fluid therapy (GDFT) can improve the postoperative recovery in patients undergoing head and neck cancer surgery. It aims to answer is: • Whether GDFT can reduce the occurrence of serious postoperative complications? Researchers will compare GDFT protocol to a standard conventional fluid therapy in head and neck cancer surgery to see if GDFT strategy works to improve the postoperative recovery. Participants will * Receive GDFT protocol or a conventional fluid therapy during the surgery. * Be continuously follow-up during hospitalization and after discharge to record the occurrence of postoperative complications.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a fluid management technique called goal-directed fluid therapy (adjusting IV fluids based on real-time heart and blood pressure monitoring) can improve recovery after major head and neck cancer surgery. **You may be eligible if...** - You are 18 or older and scheduled for head and neck cancer surgery expected to take 2 or more hours (not thyroid cancer) - You agree to arterial line monitoring during surgery **You may NOT be eligible if...** - You have very poor overall health (ASA class greater than IV) - You are having palliative surgery only - You are having minimally invasive or laser-only surgery - You had major chest or abdominal surgery in the last 30 days - You need regular dialysis - You have severe heart failure, very low heart pump function, severe lung disease, or atrial fibrillation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGoal-Directed Fluid Therapy

Stroke volume variation (SVV)≤12% and cardiac index (CI)≥2.5L/min/m2 are the goals of Goal-Directed fluid therapy, while the mean arterial pressure (MAP) are kept between 65 and 90 mmHg. 5mL/kg of crystalloids will be infused during induction period, followed by an infusion rate of 2 mL/kg/h to supplement the physiological requirements. If SVV\>12% for more than 5 min, a 250 mL bolus of colloid is given. Another 250 ml bolus of colloid is administrated if SVV was still more than 12% or SV decreased over 10%. If the CI\<2.5 L/min/m2, inotropes are used to achieve this minimum CI, serving as a safety parameter to prevent the patient from being exposure to a low cardiac output state. If SVV and CI reached the s target range but MAP could not maintain the expected level, vasopressors were started. Assess the patients every 5min intraoperatively to ensure that all parameters adhere to the target range according to the study algorithm.