Opioid-Free Anesthesia in FESS with ERAS
Official title: Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study
Run by Ankara City Hospital Bilkent · NCT07812389 · Data updated 2026-11-12
This study tries a opioid-free anesthesia approach during functional endoscopic sinus surgery to see if pain, nausea, and recovery are improved for adults undergoing this procedure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, ÇANKAYA) |
| Status | Recruiting |
| Started | August 15, 2026 |
| Main results expected | August 15, 2027 |
| Study ends | September 15, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07812389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with chronic sinusitis scheduled for elective FESS and managed under ERAS, without major exclusions.
✕Probably not a fit
Patients for whom OFA offers no advantage or who experience complications related to alternative analgesia may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study looks at perioperative outcomes in adults aged 18–65 undergoing elective FESS for chronic sinusitis who are managed with ERAS principles. Anesthesiologists choose between opioid-free anesthesia and traditional opioid-based anesthesia based on standard care, and the study follows patients from preoperative assessment through postoperative follow-up. Data collected include baseline health status, intraoperative anesthesia depth, hemodynamics, and surgical field visibility. The aim is to see whether OFA with ERAS can reduce postoperative pain and nausea and promote quicker recovery without compromising safety.
Why it matters
Potential benefit: If successful, patients may experience less pain and nausea and a faster return to normal activities after FESS.
How similar studies have gone: Previous research in other surgeries suggests opioid-sparing approaches can improve recovery, but evidence in FESS with OFA is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 18 and 65 years. * American Society of Anesthesiologists (ASA) physical status I or II. * Patients scheduled for elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis. * Patients whose perioperative care is managed strictly according to institutional Enhanced Recovery After Surgery (ERAS) principles. * Both female and male patients are eligible for inclusion. Exclusion Criteria: * Known cardiac conduction abnormalities or arrhythmias. * History of chronic opioid use or opioid dependency. * Current use of beta-blockers or antiarrhythmic medications. * Severe hepatic or renal impairment. * Obesity defined as a Body Mass Index (BMI) greater than 35 kg/m². * Current use of GLP-1 receptor agonists. * Documented coagulopathy or bleeding disorders. * History of prior revision Functional Endoscopic Sinus Surgery (FESS) procedures. * History of delayed gastric emptying or high risk of pulmonary aspiration.
Where it's running
-
Ankara Bilkent City Hospital
Ankara, Çankaya, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Filiz Kaya, M.D. — Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
- Study coordinator: Filiz Kaya, M.D
- Email: fbulut5@hotmail.com
- Phone: +903125526000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.