RecruitingNCT07812389

Opioid-Free Anesthesia in FESS: A Prospective ERAS Study

Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study


Sponsor

Filiz Kaya

Enrollment

104 participants

Start Date

Aug 15, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dexmedetomidine and a drug called Remifentanil for people with blood loss, surgical, chronic sinusitis, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexmedetomidine

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.

DRUGRemifentanil

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.


Locations(1)

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, Turkey (Türkiye)

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NCT07812389


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