Effect of goal-directed fluid therapy on the postoperative outcome in head and neck cancer surgery: study protocol for a randomized controlled trial.

BACKGROUND: 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 GDFT in patients undergoing head and neck cancer 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 standard conventional fluid therapy in patients undergoing head and neck cancer surgery. METHODS: A total of 340 adult patients who scheduled for head and neck cancer surgery will be enrolled in this prospective, single-center, partly blinded, randomized controlled trial. Both groups will receive standard general anesthesia. Participants will be randomly assigned to GDFT group (group G) or conventional fluid therapy group (group C). Patients in group G will receive GDFT protocol associated with the stroke volume variation (SVV) ≤ 12% and the cardiac index (CI) was controlled at a minimum of 2.5 L/min/m2, whereas patients in group C underwent conventional fluid therapy based on mean arterial pressure (MAP) and urine output. The primary outcome is serious postoperative complications occurred within 30 days after surgery. DISCUSSION: This study will better demonstrate whether GDFT has a positive effect on postoperative outcomes in head and neck cancer patients. Results of the study will provide evidence for selecting appropriate intraoperative fluid management methods in such patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT06468852. Registered on June 21, 2024.