GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Capital Medical University

Status: Enrolling

Conditions: Postoperative Complications

Treatments: Procedure: Goal-Directed Fluid Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06468852

TREC2024-KY059

Details and patient eligibility

About

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.

Full description

Postoperative complications have become the main cause of prolonged hospitalization and reduced postoperative survival rate among surgical patients. Goal-Directed Fluid Therapy (GDFT) has been reported to reduce the incidence of postoperative complications and mortality, shorten the hospital stay, and improve the outcome in major abdominal surgery patients. However, the benefit of the GDFT in patients undergoing head and neck surgery remains controversial. The purpose of this study is to evaluate whether GDFT can reduce the occurrence of serious postoperative complications and shorten the postoperative hospital stay, compared with a standard conventional fluid therapy in patients undergoing head and neck cancer surgery.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (Age≥18)
• Scheduled to undergo head and neck cancer surgery (including nasopharyngeal carcinoma, laryngocarcinoma, hypopharyngeal carcinoma, and other head and neck malignancies, but not thyroid cancer) with an expected duration of 2 hours or longer
• Agree to receive invasive artery blood pressure monitoring

Exclusion criteria

• American Society of Anesthesiologists (ASA) classification>Ⅳ
• Palliative surgery was performed for the terminal tumors
• Microlaryngoscopic laser surgery or endoscopic surgery
• Underwent major thoracic or abdominal surgery within 30 days
• Regular renal replacement therapy is required
• NYHA grade>3 or ejection fraction <30%
• Lung disease does not tolerate the tidal volume by 8 ml/kg
• Atrial fibrillation
• Unable to give informed consent
• pregnant or lactating woman
• Emergency surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups

GDFT group

Experimental group

Description:

Patients in GDFT group will receive GDFT protocol, Stroke volume variation (SVV)≤12% and cardiac index (CI)≥2.5L/min/m2 are the goals of 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.

Treatment:

Procedure: Goal-Directed Fluid Therapy

conventional fluid therapy group

No Intervention group

Description:

Patients in conventional fluid therapy group, fluid management will be carried out according to the clinical practice routine, maintaining MAP≥65mmHg and urine output ≥0.5ml/kg/h, intraoperatively. When the anesthesiologist empirically determines that the fluid infusion is sufficient but MAP does not maintain the expected level, vasopressor or inotropic drugs are given to maintain the blood pressure.