GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Official title

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

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.

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.

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 decrea

Primary outcome measures

• Serious complications occurred within 30 days after surgery [Time frame: within 30 days after surgery]

Secondary outcome measures (4)

• All complications within 30 days after surgery [Time frame: within 30 days after surgery]
• The length of hospital stay after surgery [Time frame: 1 months after operation]
• Cost of hospitalization [Time frame: 1 months after operation]
• Quality of Recovery Score [Time frame: At 1,3, and 5 days after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing tongren Hospital, Capital Medical University — Beijing

Publications

• Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9. PMID 22998715
• McMahon JD, MacIver C, Smith M, Stathopoulos P, Wales C, McNulty R, Handley TP, Devine JC. Postoperative complications after major head and neck surgery with free flap repair--prevalence, patterns, and determinants: a prospective cohort study. Br J Oral Maxillofac Surg. 2013 Dec;51(8):689-95. doi: 10.1016/j.bjoms.2013.04.015. Epub 2013 May 31. PMID 23727043
• Loeffelbein DJ, Julinek A, Wolff KD, Kochs E, Haller B, Haseneder R. Perioperative risk factors for postoperative pulmonary complications after major oral and maxillofacial surgery with microvascular reconstruction: A retrospective analysis of 648 cases. J Craniomaxillofac Surg. 2016 Aug;44(8):952-7. doi: 10.1016/j.jcms.2016.05.007. Epub 2016 May 14. PMID 27259678
• Liang X, Chen X, Wang G, Wang Y, Shi D, Zhao M, Zheng H, Cui X. Intraoperative hypotension, oliguria and operation time are associated with pulmonary embolism after radical resection of head and neck cancers: a case control study. BMC Anesthesiol. 2021 Dec 3;21(1):304. doi: 10.1186/s12871-021-01521-4. PMID 34856931
• Dushianthan A, Knight M, Russell P, Grocott MP. Goal-directed haemodynamic therapy (GDHT) in surgical patients: systematic review and meta-analysis of the impact of GDHT on post-operative pulmonary complications. Perioper Med (Lond). 2020 Oct 15;9:30. doi: 10.1186/s13741-020-00161-5. eCollection 2020. PMID 33072306
• Sun Y, Chai F, Pan C, Romeiser JL, Gan TJ. Effect of perioperative goal-directed hemodynamic therapy on postoperative recovery following major abdominal surgery-a systematic review and meta-analysis of randomized controlled trials. Crit Care. 2017 Jun 12;21(1):141. doi: 10.1186/s13054-017-1728-8. PMID 28602158
• Reiterer C, Kabon B, Zotti O, Obradovic M, Kurz A, Fleischmann E. Effect of goal-directed crystalloid- versus colloid-based fluid strategy on tissue oxygen tension: a randomised controlled trial. Br J Anaesth. 2019 Dec;123(6):768-776. doi: 10.1016/j.bja.2019.08.027. Epub 2019 Oct 15. PMID 31627889
• Liang X, Xi C, Zhou H, Wang S, Shi D, Wang Y, Shen W, Wang G. Effect of goal-directed fluid therapy on the postoperative outcome in head and neck cancer surgery: study protocol for a randomized controlled trial. Trials. 2025 Oct 15;26(1):412. doi: 10.1186/s13063-025-09152-7. PMID 41094585

Identifiers

NCT: NCT06468852 · TREC2024-KY059

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗