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RECRUITING
NCT06468852
NA

GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2024-05-16

Completion Date

2026-12-31

Last Updated

2024-06-21

Healthy Volunteers

No

Interventions

PROCEDURE

Goal-Directed Fluid Therapy

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.

Locations (1)

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China