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.
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.
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.
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.
Cohort
Prospective
Dexmedetomidine
DrugPatients 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.
Remifentanil
DrugPatients 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.
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).
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)
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.
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.
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.
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Filiz Kaya
Lead sponsor
Ankara City Hospital Bilkent
Sponsor institution
