Chronic SinusitisOFA-FESSNCT07812389
Opioid-Free Anesthesia in FESS: A Prospective ERAS Study
An observational study of Chronic Sinusitis and Postoperative Pain, run by Filiz Kaya at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Sinusitis, Postoperative Pain, Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients aged 18 to 65 years who are scheduled to undergo elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis at Ankara Bilkent City Hospital, a tertiary care referral and teaching hospital in Ankara, Turkey. The study population comprises consecutive eligible patients whose perioperative anesthetic and surgical management is monitored following institutional Enhanced Recovery After Surgery (ERAS) pathways.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06800
FİLİZ KAYA, M.D., 05056170718, fbulut5@hotmail.com
Ezgi Erkılıç, Prof., eerkilic72@yahoo.com
About this study
Official title: Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study
- 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.
- 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.
Read the detailed description
This prospective observational study is designed to evaluate perioperative clinical outcomes in patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) under routine clinical care. In accordance with the observational nature of the study, the investigators do not assign or control the anesthetic techniques, drug dosages, or clinical pathways. All perioperative interventions, including the choice between an opioid-free anesthesia (OFA) approach or traditional opioid-based anesthesia, are determined solely by the attending anesthesiologists based on standard institutional protocols and clinical judgment.
Data collection will encompass the entire perioperative period, spanning from the pre-anesthesia assessment until the standard post-operative follow-up intervals.
The clinical tracking workflow consists of the following phases:
- Preoperative Phase: Eligible patients scheduled for elective FESS due to chronic sinusitis are identified during routine pre-anesthesia visits. Baseline demographic characteristics, physical status according to the American Society of Anesthesiologists (ASA) classification, and relevant medical histories are documented.
- Intraoperative Phase: Standard monitoring and depth of anesthesia parameters are recorded in the operating room. Intraoperative hemodynamic data (including heart rate and mean arterial pressure) and parameters related to the surgical field quality are collected at predefined surgical milestones from the initial incision to the completion of the procedure. Total consumption of anesthetic agents and any required vasoactive medications are also logged.
- Postoperative Phase: Following extubation, patients are transferred to the Post-Anesthesia Care Unit (PACU). Early recovery characteristics, including recovery times and discharge scores, are monitored. Within the first 24 hours post-surgery, acute postoperative pain scores and the incidence or severity of postoperative nausea and vomiting (PONV) are tracked at serial clinical intervals.
- Follow-up Phase: Patient-reported outcomes regarding subjective recovery characteristics, such as postoperative sleep quality, are subsequently evaluated during the routine outpatient follow-up visit at one week postoperatively.
Statistical analyses will be performed to evaluate and compare the collected perioperative datasets between patients who received dexmedetomidine-based opioid-free anesthesia and those who received traditional opioid-based regimens under the institutional Enhanced Recovery After Surgery (ERAS) framework. No additional clinical interventions, blood samplings, or changes to standard patient care pathways are introduced due to study participation.
- Conditions
- Chronic Sinusitis, Postoperative Pain, Postoperative Nausea and Vomiting (PONV), Surgical Field Visibility, Enhanced Recovery After Surgery (ERAS) Protocol, Blood Loss, Surgical
- Being tested
- Dexmedetomidine, Remifentanil
- Keywords
- Opioid-Free Anesthesia, Functional Endoscopic Sinus Surgery, Postoperative Nausea and Vomiting, Enhanced Recovery After Surgery, Surgical Field Visibility, Blood Loss, Surgical, Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients in the Opioid-Free Anesthesia (OFA) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) with a propofol infusion. Intraoperative analgesia and hemodynamic control are managed using a dexmedetomidine infusion combined with non-opioid multimodal analgesics, embedded within an institutional ERAS pathway. Brain function monitoring (Masimo SedLine®) is used to guide anesthesia depth. No intraoperative systemic opioids are administered.
RemifentanilDrug
Patients in the Opioid (O) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) using a propofol infusion. Intraoperative analgesia is provided through a traditional remifentanil-based continuous intravenous infusion protocol, managed within the same institutional ERAS pathway.
| Study group | Role | What they receive |
|---|---|---|
| OFA Group | Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive dexmedetomidine-based Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway. No intraoperative opioids will be administered to this cohort. Receives: Drug: Dexmedetomidine | |
| O Group (Opioid Group) | Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive traditional remifentanil-based opioid anesthesia embedded within the same Enhanced Recovery After Surgery (ERAS) pathway. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the Surgical Field Assessed by Fromme-Boezaart Scoring System
Comparison of the surgical field quality between the Opioid-Free Anesthesia (OFA) group and the traditional opioid group. The quality of the surgical field visibility will be evaluated by the operating surgeon using a validated visual scoring system, such as the Fromme-Boezaart Surgical Field Scoring System (ranging from 0 = no bleeding to 5 = severe bleeding, where lower scores indicate better surgical conditions).
Measured: Perioperative/Periprocedural
Secondary outcomes (5)
Surgeon Satisfaction Score Assessed by a 5-Point Likert Scale
Assessment of the operating surgeon's overall satisfaction regarding the surgical conditions, field visibility, and patient immobility during the procedure. It will be evaluated using a 5-point Likert scale (ranging from 1 = Very Dissatisfied to 5 = Very Satisfied, where higher scores indicate a higher level of surgeon satisfaction)
Measured: Immediately after the completion of the surgical procedure.
Heart Rate (HR)
Comparison of intraoperative heart rate (measured in beats per minute) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.
Measured: Perioperative/Periprocedural
Postoperative Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Evaluation and comparison of the patient's subjective sleep quality during the first postoperative week between the two study cohorts. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which ranges from a minimum score of 0 to a maximum score of 21. A higher global score indicates worse sleep quality.
Measured: Postoperative Day 7
Mean Arterial Pressure (MAP)
Comparison of intraoperative mean arterial pressure (measured in mmHg) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.
Measured: Perioperative/Periprocedural
Severity of Postoperative Nausea and Vomiting (PONV)
Evaluation and comparison of the severity of postoperative nausea and vomiting between the two study cohorts. The severity of PONV will be assessed using a validated Visual Analog Scale (VAS) scoring system adapted from the literature: 0 = No nausea; 1 = Mild nausea; 2 = Moderate nausea; 3 = Severe nausea/vomiting. Lower scores indicate a lower burden of opioid-induced emetic side effects.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Aug 2026
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filiz Kaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Filiz Kaya, Ankara City Hospital Bilkent
- Investigators
- Filiz Kaya, M.D., Principal investigator, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812389
- Sponsor's protocol ID
- E2-26-16061
- Acronym
- OFA-FESS
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to institutional ethical committee restrictions, legal data protection regulations (KVKK), and the need to maintain strict patient privacy.
Publications
Moeen SM, Mandour AM, Soliman OM, Osman MM. Effect of lidocaine infusion on intraoperative bleeding during functional endoscopic sinus surgery: a randomized controlled trial. Minerva Anestesiol. 2022 Nov;88(11):901-909. doi: 10.23736/S0375-9393.22.16475-8. Epub 2022 Jun 29.
PubMed 35766954Wu Y, Fu Y, He Y, Gong X, Han Z, Fan H, Zhu T, Li H. The application of enhanced recovery after surgery (ERAS) in chronic rhinosinusitis patients undergoing endoscopic sinus surgery: A systematic review and meta-analysis. PLoS One. 2023 Sep 21;18(9):e0291835. doi: 10.1371/journal.pone.0291835. eCollection 2023.
PubMed 37733792Shen Y, Wu Y, Tang Q, Wang Y, Ma W, Wang J. Efficacy of opioid-free anesthesia in reducing postoperative nausea and vomiting following gynecological laparoscopic surgery: a randomized controlled trial. Front Med (Lausanne). 2025 Jul 17;12:1606383. doi: 10.3389/fmed.2025.1606383. eCollection 2025.
PubMed 40747089Moffatt DC, McQuitty RA, Wright AE, Kamucheka TS, Haider AL, Chaaban MR. Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Am J Rhinol Allergy. 2021 Sep;35(5):674-684. doi: 10.1177/1945892421989155. Epub 2021 Jan 21.
PubMed 33478255Karabayirli S, Ugur KS, Demircioglu RI, Muslu B, Usta B, Sert H, Ark N. Surgical conditions during FESS; comparison of dexmedetomidine and remifentanil. Eur Arch Otorhinolaryngol. 2017 Jan;274(1):239-245. doi: 10.1007/s00405-016-4220-1. Epub 2016 Jul 28.
PubMed 27470115