GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Trial Title: GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

NCT ID: NCT06468852

Condition: Postoperative Complications

Conditions: Official terms:
Head and Neck Neoplasms
Postoperative Complications

Conditions: Keywords:
Postoperative Complications
Early Goal-Directed Therapy
Fluid therapy
Head and Neck Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking description: Patients were unaware of their group allocation. Due to the presence of the cardiac index trend monitoring device, care providers who supported to fluid strategy administration in the operating room could not be blinded. The outcomes assessor were blinded to the allocation.

Intervention:

Intervention type: Procedure
Intervention name: Goal-Directed Fluid Therapy
Description: 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.
Arm group label: GDFT group

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.

Criteria for 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 - Emergency surgery

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing tongren Hospital, Capital Medical University

Address:
City: Beijing
Zip: 100730
Country: China

Status: Recruiting

Contact:
Last name: Guyan Wang

Phone: +8613910985139
Email: guyanwang2006@163.com

Start date: May 16, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Beijing Tongren Hospital
Agency class: Other

Source: Beijing Tongren Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06468852