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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing tongren Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xuan Liang, master
doctor_xuan@hotmail.com
+8613810261846
Time Frame
Start Date: 2024-05-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 340
Treatments
Experimental: GDFT group
Patients in GDFT group will receive GDFT protocol, Stroke volume variation (SVV)≤12% and cardiac index (CI)≥2.5L/min/m2 are the goals of 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.
No_intervention: conventional fluid therapy group
Patients in conventional fluid therapy group, fluid management will be carried out according to the clinical practice routine, maintaining MAP≥65mmHg and urine output ≥0.5ml/kg/h, intraoperatively. When the anesthesiologist empirically determines that the fluid infusion is sufficient but MAP does not maintain the expected level, vasopressor or inotropic drugs are given to maintain the blood pressure.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tongren Hospital

This content was sourced from clinicaltrials.gov