Evaluating fluid therapy for recovery after 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
This study is testing if a special way of giving fluids during surgery can help people recover better after having head and neck cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06468852 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of goal-directed fluid therapy (GDFT) in improving postoperative recovery for patients undergoing head and neck cancer surgery. Participants will be randomly assigned to receive either GDFT or standard fluid therapy during their surgery. The study will monitor and compare the occurrence of postoperative complications and the length of hospital stays between the two groups. Continuous follow-up will be conducted during hospitalization and after discharge to gather comprehensive data on recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult patients scheduled for head and neck cancer surgery lasting two hours or longer who can consent to invasive monitoring.
Not a fit: Patients with severe comorbidities, those undergoing palliative surgery, or those requiring emergency procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery times for patients undergoing head and neck cancer surgery.
How similar studies have performed: Previous studies have shown that GDFT can reduce postoperative complications in major abdominal surgeries, but its effectiveness in head and neck surgeries remains under investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Beijing tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Guyan Wang — Beijing Tongren Hospital, CMU
- Study coordinator: Xuan Liang, master
- Email: doctor_xuan@hotmail.com
- Phone: +8613810261846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.