Clinical trial · Interventional
GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery
Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial
NCT06468852CI-TRIAL-00078115recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal-Directed Fluid Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GDFT group
- description
- 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.
- interventionNames
- Procedure: Goal-Directed Fluid Therapy
- type
- NO_INTERVENTION
- label
- conventional fluid therapy group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDPearse 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
- BACKGROUNDMcMahon 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
- BACKGROUNDLoeffelbein 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
- BACKGROUNDLiang 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
- BACKGROUNDDushianthan 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
- BACKGROUNDSun 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.