NCT07812389 Opioid-Free Anesthesia in FESS: A Prospective ERAS Study
| NCT ID | NCT07812389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Filiz Kaya |
| Condition | Chronic Sinusitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2027-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2026-08-15 with a primary completion date of 2027-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
1. Information for Patients and Families What is this study about? When patients undergo functional endoscopic sinus surgery (FESS), strong pain relievers called opioids are traditionally used during anesthesia. While effective, opioids can sometimes cause unwanted side effects such as nausea, vomiting, dizziness, or prolonged recovery times. This study investigates an "Opioid-Free Anesthesia" (OFA) approach combined with Enhanced Recovery After Surgery (ERAS) protocols. ERAS is a modern, science-based care pathway designed to help patients recover faster and more comfortably after surgery. Why is this study important? The goal of this study is to see if skipping opioids during sinus surgery-and using alternative pain-management techniques instead-leads to better perioperative outcomes. We want to find out if patients experience less pain, fewer side effects (like nausea), and a quicker, safer return to their daily routines. What will happen if you participate? If you fit the criteria and agree to join, your surgical journey will follow the standard ERAS protocol, but your anesthesia will be managed without conventional opioid medications. Researchers will closely monitor your comfort, pain levels, and recovery speed before, during, and after your sinus surgery. 2. Technical Summary for Health Care Providers Official Study Title: Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study Study Rationale and Objective: Traditional opioid-based anesthesia is often associated with opioid-induced side effects (OIAEs) such as postoperative nausea and vomiting (PONV), respiratory depression, and delayed discharge. This prospective observational study aims to evaluate the clinical impact of Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway for patients undergoing elective Functional Endoscopic Sinus Surgery (FESS). The primary focus is to assess whether an OFA-ERAS strategy optimizes perioperative outcomes, stabilizes intraoperative hemodynamics, and minimizes recovery times compared to historical opioid-based standards. Study Design: Prospective, Observational Study. Estimated Enrollment: 104 patients. Setting: Perioperative tracking following strict institutional ERAS principles.
Eligibility 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.
Contact & Investigator
Filiz Kaya, M.D.
PRINCIPAL INVESTIGATOR
Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
Frequently Asked Questions
Who can join the NCT07812389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Sinusitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07812389 currently recruiting?
Yes, NCT07812389 is actively recruiting participants. Contact the research team at fbulut5@hotmail.com for enrollment information.
Where is the NCT07812389 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07812389 clinical trial?
NCT07812389 is sponsored by Filiz Kaya. The principal investigator is Filiz Kaya, M.D. at Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation. The trial plans to enroll 104 participants.