GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Beijing Tongren Hospital340 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

340

Conditions

Postoperative Complications

Interventions

Goal-Directed Fluid TherapyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serious complications occurred within 30 days after surgery

Unit: %; All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications. Each complication has an equal weight, and patients with at least one complication will be considered to have experienced postoperative complications. The serious postoperative complications were defined as CDc≥3.

Time frame: within 30 days after surgery

Secondary Outcomes

All complications within 30 days after surgery

Unit: %;All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications.

Time frame: within 30 days after surgery

The length of hospital stay after surgery

Unit: days; from date of operation till date of discharge

Time frame: 1 months after operation

Cost of hospitalization

Unit: yuan; Total cost during hospitalization

Time frame: 1 months after operation

Quality of Recovery Score

Unit: point; Use QoR-15 to evaluate the postoperative recovery of all patients. QoR-15 is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).

Time frame: At 1,3, and 5 days after surgery