Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Complications
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Serious complications occurred within 30 days after surgery
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Serious complications occurred within 30 days after surgery
Time Frame: 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.
Secondary Outcomes
- All complications within 30 days after surgery(within 30 days after surgery)
- Cost of hospitalization(1 months after operation)
- The length of hospital stay after surgery(1 months after operation)
- Quality of Recovery Score(At 1,3, and 5 days after surgery)